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Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2).
Chey, WD, Lembo, AJ, Yang, Y, Rosenbaum, DP
The American journal of gastroenterology. 2021;(6):1294-1303
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Abstract
INTRODUCTION Tenapanor is a first-in-class, minimally absorbed, small-molecule inhibitor of the gastrointestinal sodium/hydrogen exchanger isoform 3. This phase 3 trial assessed the long-term efficacy and safety of tenapanor 50 mg b.i.d. for the treatment of patients with irritable bowel syndrome with constipation (IBS-C). METHODS In this randomized double-blind study (ClinicalTrials.gov identifier: NCT02686138), patients with IBS-C received tenapanor 50 mg b.i.d. or placebo b.i.d. for 26 weeks. The primary endpoint was the proportion of patients who had a reduction of ≥30.0% in average weekly worst abdominal pain and an increase of ≥1 weekly complete spontaneous bowel movement from baseline, both in the same week, for ≥6 of the first 12 treatment weeks (6/12-week combined responder). RESULTS Of the 620 randomized patients with IBS-C, 593 (95.6%) were included in the intention-to-treat analysis set (tenapanor: n = 293; placebo: n = 300) and 481 patients (77.6%) completed the 26-week treatment period. In the intention-to-treat analysis set (mean age: 45.4 years; 82.1% women), a significantly greater proportion of patients treated with tenapanor were 6/12-week combined responders than those treated with placebo (36.5% vs 23.7%; P < 0.001). Abdominal symptoms and global symptoms of IBS were significantly improved with tenapanor compared with placebo. Diarrhea, the most common adverse event, was typically transient and mild to moderate in severity. Diarrhea led to study drug discontinuation for 19 (6.5%) and 2 patients (0.7%) receiving tenapanor and placebo, respectively. DISCUSSION Tenapanor 50 mg b.i.d. improved IBS-C symptoms over 26 weeks and was generally well tolerated, offering a potential new long-term treatment option for patients with IBS-C (see Visual abstract, Supplementary Digital Content 1, http://links.lww.com/AJG/B797).
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Nopal fiber (Opuntia ficus-indica) improves symptoms in irritable bowel syndrome in the short term: a randomized controlled trial.
Remes-Troche, JM, Taboada-Liceaga, H, Gill, S, Amieva-Balmori, M, Rossi, M, Hernández-Ramírez, G, García-Mazcorro, JF, Whelan, K
Neurogastroenterology and motility. 2021;(2):e13986
Abstract
BACKGROUND Clinical guidelines provide limited and conflicting recommendations regarding dietary fiber supplementation in irritable bowel syndrome (IBS). Nopal (Opuntia ficus-indica) is a cactus plant fiber containing both insoluble and soluble fibers that may have therapeutic potential in IBS. Our aim was to evaluate the dose-response effect of extracted nopal fiber powder on symptoms in IBS. METHODS We performed a 4-arm, double-blind, parallel, randomized controlled trial in 60 patients fulfilling Rome IV criteria for IBS. Patients were randomized and blindly allocated to receive either nopal fiber (10, 20, or 30 g/day) or placebo (30 g/day dextrose) for one week and to keep their usual diet. Symptom severity (Global Symptom Question, IBS-SSS, Gastrointestinal Symptom Rating Scale), stool frequency and consistency (Bristol Stool Form Scale), breath hydrogen response, and stool short-chain fatty acids (SCFA) were measured at baseline and follow-up. KEY RESULTS Significantly more patients reported adequate relief of symptoms after 20 g/day (87%, p = 0.008) and 30 g/day (80%, p = 0.025) of nopal fiber compared to placebo (33%). More patients receiving 20 g/day nopal fiber (67%) had a > 50% reduction in IBS-SSS compared to placebo (20%, p = 0.027), whereas the 30 g/day dose induced more loose stools (p = 0.027). Response rates were similar among IBS subtypes. There were no differences in breath hydrogen or stool SCFA between groups. CONCLUSIONS AND INFERENCES Nopal fiber supplementation at doses of 20 and 30 g/day was associated with short-term improvement in IBS symptoms, warranting a fully powered clinical trial of longer duration with symptomatic, physiological, and microbiological endpoints.
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Efficacy and safety of Bacillus coagulans LBSC in irritable bowel syndrome: A prospective, interventional, randomized, double-blind, placebo-controlled clinical study [CONSORT Compliant].
Gupta, AK, Maity, C
Medicine. 2021;(3):e23641
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GOALS To evaluate safety and efficacy of Bacillus coagulans LBSC [DSM17654] in irritable bowel syndrome (IBS) through a prospective, interventional, randomized, double-blind, and placebo-controlled, CONSORT compliant clinical trial. BACKGROUND Bacteriotherapy shows promising impact on alleviating clinical conditions of IBS and associated functional gastrointestinal disorders. B coagulans LBSC is a genetically and phenotypically safe probiotic strain used in this study to study its impact on ameliorating IBS symptoms and improving quality of life. METHODS In this interventional, randomized, double-blind, placebo-controlled clinical study, total 40 subjects (18-65 years) were screened through Rome IV criteria and randomized into 2 groups, that is, interventional and placebo arm (n = 20/arm). Similar dosages were received by both the arm, that is, placebo (vehicle) and interventional arm (B coagulans LBSC, 6 billion/d) for a period of 80 days. Study completed with per protocol subjects (n = 38) and results were considered to evaluate the primary and secondary endpoints. RESULTS Assessment through Digestive Symptom Frequency Questionnaire 5 point Likert scale showed significant improvement in interventional arm compared to placebo on symptoms such as bloating/cramping, abdominal pain, diarrhea, constipation, stomach rumbling, nausea, vomiting, headache, and anxiety. Maximum of "no symptoms" cases and mild to moderate gastrointestinal symptoms along with improved stool consistency were from interventional arm tested following IBS severity scoring system and Bristol stool form scale. Upper gastrointestinal endoscopy revealed no clinical difference of gastrointestinal mucosa between both the arms. B coagulans LBSC was well tolerated with no serious adverse events. CONCLUSIONS B coagulans LBSC was safe for human consumption and efficacious in alleviating overall pathophysiological symptoms of IBS and thereby improving inclusive quality of life evaluated.
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Combination of a Probiotic and an Antispasmodic Increases Quality of Life and Reduces Symptoms in Patients with Irritable Bowel Syndrome: A Pilot Study.
Barraza-Ortiz, DA, Pérez-López, N, Medina-López, VM, Minero-Alfaro, JI, Zamarripa-Dorsey, F, Fernández-Martínez, NDC, Llorente-Ramón, A, Ramos-Aguilar, GA
Digestive diseases (Basel, Switzerland). 2021;(3):294-300
Abstract
BACKGROUND Probiotics and antispasmodics have been tested extensively in the management of symptoms of irritable bowel syndrome (IBS), but they have rarely been evaluated in combination. The objective of this pilot study was to assess the efficacy of treatment with the probiotic formulation i3.1 (Lactobacillus plantarum CECT7484 and CECT7485 and Pediococcus acidilactici CECT7483), with or without the addition of the antispasmodic alverine/simethicone, in improving IBS-related quality of life (QoL) and reducing abdominal pain and diarrhea in patients with IBS. METHODS This was a randomized, placebo-controlled clinical trial with 3 parallel arms (probiotic, probiotic plus antispasmodic, and placebo). Patients with IBS (N = 55) were recruited at the Gastroenterology Department of the Juárez Hospital (México City). QoL was assessed with the IBS-QoL questionnaire, abdominal pain with a visual analog scale, and stool consistency with the Bristol scale. RESULTS The IBS-QoL rate of response (ITT analysis) was 50.0% for patients in the group with probiotic alone, 68.4% in the group with probiotic plus antispasmodic, and 16.7% in the group with placebo after 6 weeks of treatment (p = 0.005). Response to abdominal pain was reported by 38.9% of patients treated with probiotic, 57.9% with probiotic plus antispasmodic, and 16.7% with placebo (p = 0.035). Regarding stool consistency, a response to treatment was reported by 44.4% of patients treated with probiotic, 57.9% with probiotic plus antispasmodic, and 16.7% with placebo (p = 0.032). CONCLUSION The results are consistent with previous studies on the use of the i3.1 probiotic formulation for the management of symptoms in IBS patients, and the addition of an antispasmodic improves its observed effects.
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Hypnotherapy for Irritable Bowel Syndrome-Type Symptoms in Patients with Quiescent Inflammatory Bowel Disease: A Randomized, Controlled Trial.
Hoekman, DR, Vlieger, AM, Stokkers, PC, Mahhmod, N, Rietdijk, S, de Boer, NK, de Meij, TG, Frankenhuis, C, D'Haens, GR, Benninga, MA
Journal of Crohn's & colitis. 2021;(7):1106-1113
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BACKGROUND AND AIMS Many inflammatory bowel disease [IBD] patients in remission have persisting symptoms, compatible with irritable bowel syndrome [IBS-type symptoms]. We aimed to compare the effectiveness of gut-directed hypnotherapy vs standard medical treatment [SMT] for IBS-type symptoms in IBD patients. METHODS In this multicentre, randomized, controlled, open-label trial, patients aged 12-65 years with IBD in clinical remission [global assessment] and biochemical remission [faecal calprotectin ≤100 µg/g, or ≤200 µg/g without inflammation at endoscopy] with IBS according to Rome III criteria were randomized to hypnotherapy or SMT. Primary outcome was the proportion with ≥50% reduction on a visual analog scale for symptom severity, as measured with the Irritable Bowel Syndrome Severity Scoring System [IBS-SSS] at week 40 [i.e. 6 months after finishing the intervention], compared to baseline. Secondary outcomes included total IBS-SSS score, quality of life, adequate relief, IBS-related cognitions, and depression and anxiety scores. RESULTS Eighty patients were included, of whom 70 received at least one session of the allocated treatment and were included in the modified intention-to-treat-population. Seven patients were excluded because of missing baseline data required for the primary outcome. The primary outcome was met in nine [27%] of 33 patients randomized to SMT and nine [30%] of 30 patients randomized to hypnotherapy [p = 0.81]. Adequate relief was reported in 60% and 40% of subjects, respectively. Exploratory analyses of secondary outcomes revealed no apparent differences between the two treatment groups. CONCLUSIONS Hypnotherapy was not superior to SMT in the treatment of IBS-type symptoms in IBD patients. Both treatment strategies are reasonable options from a clinical perspective.
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Symptom-network dynamics in irritable bowel syndrome with comorbid panic disorder using electronic momentary assessment: A randomized controlled trial of escitalopram vs. placebo.
Kreiter, D, Drukker, M, Mujagic, Z, Vork, L, Rutten, BPF, van Os, J, Masclee, AAM, Kruimel, JW, Leue, C
Journal of psychosomatic research. 2021;:110351
Abstract
INTRODUCTION Momentary ecological assessment indicated alleviated abdominal pain in escitalopram treatment of irritable bowel syndrome (IBS) with comorbid panic disorder. Hitherto, little is known about symptom formation, i.e., how psychological impact physical symptoms, and vice versa, and about the effect of SSRI-treatment on symptom formation. OBJECTIVE To investigate how psychological and somatic symptoms co-vary over time in IBS patients with comorbid panic disorder and how they are affected by escitalopram treatment. METHODS Experience sampling data from 14 IBS patients with panic disorder were obtained from a single-centre, double-blind, parallel-group, randomized controlled trial on escitalopram versus placebo. At baseline, after three and six months, multilevel time-lagged linear regression analysis was used to construct symptom networks. Network connections represented coefficients between various affect and gastrointestinal items. RESULTS Connectivity increased up to 3 months in both groups. Between 3 and 6 months, connectivity decreased for placebo and further increased in the escitalopram group. Additionally, a steep increase in node strength for negative affect nodes was observed in the escitalopram network and the opposite for positive affect nodes. Over time, group symptom networks became increasingly different from each other. Anxious-anxious and enthusiastic-relaxed became significantly different between groups at 6 months. The connection that changed significantly in all analyses was anxious-anxious. CONCLUSIONS Escitalopram treatment was associated with changes in the symptom networks in IBS patients with panic disorder. While mood and physical symptoms improve over time, mainly connectivity between mood nodes changed, possibly pointing towards a healthier emotion regulation resulting in alleviation of physical symptoms.
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Anti-irritable Bowel Syndrome Syrup Improves Constipation-Predominant Irritable Bowel Syndrome: A Randomized, Placebo-Controlled Trial.
Pazhouh, HK, Hosseini, SMA, Taghipour, A, Hamedi, S, Noras, M
Chinese journal of integrative medicine. 2020;(10):729-735
Abstract
OBJECTIVE To evaluate the efficacy and safety of administration of the formulated Persian herbal syrup on improving the symptoms of patients with constipation-predominant irritable bowel syndrome (IBS-C). METHODS This study was conducted in 70 patients with IBS-C, who were recruited from 3 medical centers in Mashhad, Iran, from November 2017 to August 2018. Seventy patients were randomly assigned to 2 groups including treatment and placebo groups by block randomization, 35 cases in each group. Patients in the treatment group received 15 mL of anti-IBS syrup, thrice daily for 6 weeks and followed up for 4 weeks. Placebo syrup was also prepared through similar instruction, BP syrup without plant extract was used. Primary outcome induding IBS Symptom Severity Scale (IBS-SSS) questionnaire and secondary outcomes in terms of Hospital Anxiety and Depression (HADS) questionnaires, the Bristol Stool Form Scale (BSFS) were completed and evaluated at weeks 6 and 10, respectively. Safety indices were collected at the end of the treatment and Common Terminology Criteria for Adverse Events v4.0 (CTCAE) was used to evaluate the adverse events. RESULTS The response to treatment was 84.4% (27/32) in the treatment group and 46.4% (13/28) in the placebo group, respectively (P= 0.002). Compared with pre-treatment, a significant decrease was found on the IBS-SSS and BSFS scores after 6-week intervention in both groups (P<0.001). Moreover, IBS-SSS and BSFS scores in the treatment group were lower than the placebo group after the intervention (P=0.041). There was no significant difference in the anxiety and depression scores after treatment in both groups (P>0.05). Side effects reported in the treatment group included 2 cases of headache during the first week of the onset of the treatment, 1 case of drowsiness, 1 case of increase in menstrual bleeding, which did not result in discontinuation of the treatment. In the placebo group, 1 case of exacerbation of the disease was reported. CONCLUSIONS Anti-IBS syrup significantly reduced the severity of IBS symptoms compared to placebo. However, there was a need for further investigation regarding the anxiety and depression scores. (Registration No. IRCT2017061034446N1).
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Nutrient Intake, Diet Quality, and Diet Diversity in Irritable Bowel Syndrome and the Impact of the Low FODMAP Diet.
Staudacher, HM, Ralph, FSE, Irving, PM, Whelan, K, Lomer, MCE
Journal of the Academy of Nutrition and Dietetics. 2020;(4):535-547
Abstract
BACKGROUND Individuals with irritable bowel syndrome (IBS) may modify their diet, which may pose nutritional risk. Further, some dietary approaches, such as a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs), are restrictive and may contribute to nutritional inadequacy. OBJECTIVE Our aim was to evaluate habitual nutrient intake, diet quality, and diversity in IBS and the effect of a 4-week low FODMAP diet on these parameters compared with controls. DESIGN Data from two randomized controlled trials were included for this secondary analysis. Participants were randomized to low FODMAP diet (n=63) or control diet (sham diet n=48, habitual diet n=19). PARTICIPANTS/SETTING Participants included 130 individuals with IBS referred to a tertiary center in London, UK between January 2010 to June 2011 and January 2013 to November 2014. INTERVENTION Participants in one trial were randomized to receive either low FODMAP dietary counseling or sham control dietary counseling. In the other, they were randomized to receive low FODMAP dietary counseling or to continue habitual diet. All advice was provided by a specialist dietitian. MAIN OUTCOME MEASURES Habitual (usual) dietary intake at baseline (n=130) and after a 4-week intervention period was measured using 7-day food records. STATISTICAL ANALYSES PERFORMED Analysis of covariance and χ2 tests evaluated differences across groups at 4 weeks. RESULTS When examining habitual intake of individuals with IBS, fiber intake was low, with only 6 (5%) achieving the target (30 g/day). In those receiving low FODMAP advice, there was no difference in intake of most nutrients compared with controls. However, there was lower intake of starch (109 g/day) vs habitual control diet (128 g/day; P=0.030), and higher intake of vitamin B-12 (6.1 μg/day) vs habitual (3.9 μg/day) and sham control diets (4.7 μg/day; P<0.01). Overall scores for diet quality were lower after low FODMAP advice vs habitual control diet (P<0.01). CONCLUSION This study demonstrates many individuals with IBS fail to meet dietary reference values for multiple nutrients. A 4-week low FODMAP diet, when delivered by a specialist dietitian, does not impact on intake of most nutrients or diet diversity but decreases diet quality compared with control diets.
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Reduced efficacy of low FODMAPs diet in patients with IBS-D carrying sucrase-isomaltase (SI) hypomorphic variants.
Zheng, T, Eswaran, S, Photenhauer, AL, Merchant, JL, Chey, WD, D'Amato, M
Gut. 2020;(2):397-398
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Vitamin D3 Supplementation in Diarrhea-Predominant Irritable Bowel Syndrome Patients: The Effects on Symptoms Improvement, Serum Corticotropin-Releasing Hormone, and Interleukin-6 - A Randomized Clinical Trial.
Khalighi Sikaroudi, M, Mokhtare, M, Janani, L, Faghihi Kashani, AH, Masoodi, M, Agah, S, Abbaspour, N, Dehnad, A, Shidfar, F
Complementary medicine research. 2020;(5):302-309
Abstract
OBJECTIVES This study aimed to evaluate whether vitamin D deficiency is associated with the severity of symptoms of irritable bowel syndrome (IBS) patients. Stress and gut inflammation can increase the serum level of corticotropin-releasing hormone (CRH) and interleukin-6 (IL-6), leading to a change in bowel movements. The aim of this study was to evaluate the anti-inflammatory and psychological effects of vitamin D3 supplementation on the symptom improvement of patients with a diarrhea-predominant form of IBS (IBS-D). METHODS Eighty-eight IBS-D patients (age: 18-65 years) based on Rome IV criteria who suffered from vitamin D deficiency and/or insufficiency were enrolled in this randomized, placebo-controlled trial from February 2017 to May 2018 at Rasoul-e-Akram Hospital, Tehran, Iran. Participants were randomly divided into two groups. The intervention group received 50,000 IU vitamin D3 weekly and the control group received a placebo for 9 weeks. All patients received Mebeverine 135 mg twice a day besides supplementation. The IBS Severity Score System (IBS-SSS), serum 25(OH) vitamin D3, CRH, and IL-6 were measured before and after interventions. RESULTS Seventy-four patients completed the study. The severity of IBS symptoms (p < 0.01) and IL-6 (p = 0.02) decreased significantly in the intervention group as compared to the control group, but there was no significant difference in the serum level of CRH. Also, in the treatment group, IBS-SSS and IL-6 were significantly reduced at the end of the study from baseline (p < 0.01 and p < 0.03, respectively). CONCLUSION Our findings indicate that vitamin D3 supplementation can modulate the serum level of CRH and IL-6 and can improve symptoms in IBS-D patients. Vitamin D3 supplementation should be considered in IBS-D patients who suffer from vitamin D deficiency and/or insufficiency.