-
1.
Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet compared with traditional dietary advice for diarrhea-predominant irritable bowel syndrome: a parallel-group, randomized controlled trial with analysis of clinical and microbiological factors associated with patient outcomes.
Zhang, Y, Feng, L, Wang, X, Fox, M, Luo, L, Du, L, Chen, B, Chen, X, He, H, Zhu, S, et al
The American journal of clinical nutrition. 2021;(6):1531-1545
-
-
Free full text
-
Abstract
BACKGROUND The efficacy and factors associated with patient outcomes for a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (LFD) compared with traditional dietary advice (TDA) based on modified National Institute for Clinical Excellence guidelines for irritable bowel syndrome with diarrhea (IBS-D) in regions consuming a non-Western diet are unclear. OBJECTIVES We aimed to determine the efficacy of an LFD compared with TDA for the treatment of IBS-D in Chinese patients and to investigate the factors associated with favorable outcomes. METHODS One hundred and eight Chinese IBS-D patients (Rome III criteria) were randomly assigned to an LFD or TDA. The primary endpoint was a ≥50-point reduction in the IBS Severity Scoring System at 3 wk. Fecal samples collected before and after the dietary intervention were assessed for changes in SCFAs and microbiota profiles. A logistic regression model was used to identify predictors of outcomes. RESULTS Among the 100 patients who completed the study, the primary endpoint was met in a similar number of LFD (30 of 51, 59%) and TDA (26 of 49, 53%) patients (∆6%; 95% CI: -13%, 24%). Patients in the LFD group achieved earlier symptomatic improvement in stool frequency and excessive wind than those following TDA. LFD reduced carbohydrate-fermenting bacteria such as Bifidobacterium and Bacteroides, and decreased saccharolytic fermentation activity. This was associated with symptomatic improvement in the responders. High saccharolytic fermentation activity at baseline was associated with a higher symptom burden (P = 0.01) and a favorable therapeutic response to the LFD (log OR: 4.9; 95% CI: -0.1, 9.9; P = 0.05). CONCLUSIONS An LFD and TDA each reduced symptoms in Chinese IBS-D patients; however, the LFD achieved earlier symptomatic improvements in stool frequency and excessive wind. The therapeutic effect of the LFD was associated with changes in the fecal microbiota and the fecal fermentation index. At baseline, the presence of severe symptoms and microbial metabolic dysbiosis characterized by high saccharolytic capability predicted favorable outcomes to LFD intervention.This trial was registered at clinicaltrials.gov as NCT03304041.
-
2.
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.
-
3.
Associations between intestinal parasitic infections, anaemia, and diarrhoea among school aged children, and the impact of hand-washing and nail clipping.
Mahmud, MA, Spigt, M, Bezabih, AM, Dinant, GJ, Velasco, RB
BMC research notes. 2020;(1):1
Abstract
OBJECTIVE In marginalized setting, under-nutrition and illnesses due to infectious agents create a vicious circle. In our previous study, we reported that easy-to-do hand hygiene interventions were effective in preventing intestinal parasite infections (IPIs) and reduce the rate of anaemia among school-aged children. The aim of this study was to assess the pattern of associations between IPIs, anaemia and diarrhoea among the school-aged children and to explore if the observed impact of hand-washing and nail clipping interventions in our findings was similar across children with different baseline demographic and disease characteristics. The study was based on the analysis of data that was collected during the randomized controlled trial and hence have used the same study participants and study area. RESULTS Children with IPIs had a much higher chance of also being anaemic (AOR 2.09, 95% CI 1.15-3.80), having diarrhoea (AOR 2.83, 95% CI 1.57-5.09), and vice versa. Anaemia and diarrhoea were very strongly related (AOR 9.62, 95% CI 5.18-17.85). Overall, hand-washing with soap at key times and weekly nail clipping were efficacious in preventing intestinal parasite re-infection among children despite the differences in baseline demographic characteristics. TRIAL REGISTRATION NCT01619254 (June 09/2012).
-
4.
Colloidal Silicon Dioxide in Tablet form (Carbowhite) Efficacy in Patients with Acute Diarrhea: Results of Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study.
Tieroshyn, V, Moroz, L, Prishliak, O, Shostakovich-Koretska, L, Kruglova, O, Gordienko, L
Scientific reports. 2020;(1):6344
Abstract
The acute diarrhea is a wide-spread disease. The prescription of enterosorbents is appropriate as a primary measure for the treatment of the acute diarrhea for effective prevention of the fluid and electrolyte loss, as well as method for symptom relief of the attack of the disease. Aim of the study - the antidiarrheal efficacy and safety study of high-dispersion silicon dioxide enterosorbent in tablet dosage form in patients with acute diarrhea. This was randomized, double-blind, placebo-controlled, 4-center study. Acute diarrhea was defined as three and more episodes of watery stool per day either during 48 hours or less before study entry in the patients having normal stool recently. It has been postulated that symptoms and signs of acute diarrhea have to be caused by direct infection of the gastrointestinal tract and did not associated with moderate-to-severe systemic states. 144 patients with established acute diarrhea were randomized into treatment group (enterosorbent "Carbowhite", n = 120) or placebo group. Date collection including severity diarrhea, systemic symptoms was performed at baseline and daily during 7 days. Stool examination and serological assay were performed at baseline. The primary end points were declared as time to complete recovery from acute diarrhea. It has been found that the use of the siliceous enterosorbent ("Carbowhite") allowed to reduce (p < 0.001) the treatment period averagely for 0.9 days (95% confidence interval 0.5-1.2 days) in comparison with placebo. Data of safety monitoring has revealed that both patient groups had negative stool culture, while initiation of antibiotic treatment was run more frequently in placebo group (8.3%) compared to investigational product group (4.1%, P = 0.044). The siliceous enterosorbent "Carbowhite" was well tolerated and reduced the recovery time of the acute episode of the diarrhea in the clinically significant form.
-
5.
Putative Probiotic Strains Isolated from Kefir Improve Gastrointestinal Health Parameters in Adults: a Randomized, Single-Blind, Placebo-Controlled Study.
Wang, MC, Zaydi, AI, Lin, WH, Lin, JS, Liong, MT, Wu, JJ
Probiotics and antimicrobial proteins. 2020;(3):840-850
Abstract
The dairy products remain as the largest reservoir for isolation of probiotic microorganisms. While probiotics have been immensely reported to exert various health benefits, it is also a common notion that these health potentials are strain and host dependent, leading to the need of more human evidence based on specific strains, health targets, and populations. This randomized, single-blind, and placebo-controlled human study aimed to evaluate the potential benefits of putative probiotic strains isolated from kefir on gastrointestinal parameters in fifty-six healthy adults. The consumption of AB-kefir (Bifidobacterium longum, Lactobacillus acidophilus, L. fermentum, L. helveticus, L. paracasei, L. rhamnosus, and Streptococcus thermophiles; total 10 log CFU/sachet) daily for 3 week reduced symptoms of abdominal pain, bloating (P = 0.014), and appetite (P = 0.041) in male subjects as compared to the control. Gut microbiota distribution profiles were shifted upon consumption of AB-kefir compared to baseline, where the abundance of bifidobacteria was increased in male subjects and maintained upon cessation of AB-kefir consumption. The consumption of AB-kefir also increased gastrointestinal abundance of total anaerobes (P = 0.038) and total bacterial (P = 0.049) in female subjects compared to the control after 3 weeks. Our results indicated that AB-kefir could potentially be developed as a natural strategy to improve gastrointestinal functions in adults.
-
6.
Effect of Ubiquinol Intake on Defecation Frequency and Stool Form: A Prospective, Double-Blinded, Randomized Control Study.
Suzuki, S, Gotoda, T, Kusano, C, Ikehara, H, Miyakoshi, Y, Fujii, K
Journal of medicinal food. 2019;(1):81-86
Abstract
Bowel habits affect the quality of life (QOL) of patients with functional gastrointestinal disorders. This study evaluated the effects of reduced form coenzyme Q 10 (ubiquinol) intake on defecation frequency and stool form in patients with daily abdominal symptoms. This was a single-center, prospective, double-blind, randomized control study. Forty-one patients who had the daily symptom of constipation or diarrhea were randomly assigned at a 1:1 ratio to receive either ubiquinol (150 mg/day) or placebo for 12 weeks. Patients completed a daily diary to collect information regarding their numbers of defecations and stool forms according to the Bristol Stool Form (BSF) Scale for 7 days at baseline and 12 weeks. QOL was assessed using the 36-item short-form (SF-36) at baseline and 12 weeks. Twenty-one patients were assigned to the ubiquinol group, and 20 were assigned to the placebo group. At 12 weeks, the mean defecation frequency, compared to baseline, significantly decreased in the ubiquinol group (-0.1 times/day, P = .034) and increased in the placebo group (+0.3 times/day, P = .004). There was no significant change in the 12-week BSF Scale score of the ubiquinol group (+0.2, P = .123), whereas that of the placebo group was increased (+0.5, P < .001). The 12-week general health perception SF-36 score was significantly increased in the ubiquinol group (+3.5, P = .045), whereas there was no significant difference in that score in the placebo group (+1.2, P = .178). In conclusion, taking ubiquinol for 12 weeks decreased defecation frequencies and increased the QOL score, suggesting that ubiquinol may change the bowel habits and improve QOL in patients with abdominal distress.
-
7.
A randomized controlled, open-label early phase II trial comparing incidence of FOLFIRI.3-induced diarrhoea between Hangeshashinto and oral alkalization in Japanese patients with colorectal cancer.
Yamazaki, K, Ariyoshi, N, Miyauchi, H, Ohira, G, Kaneya, N, Yamamoto, K, Arai, K, Yamazaki, S, Matsubara, H, Suzuki, T, et al
Journal of clinical pharmacy and therapeutics. 2019;(6):946-951
Abstract
WHAT IS KNOWN AND OBJECTIVE We conducted a pilot clinical trial to investigate whether Hangeshashinto (TJ-14) could be substituted for oral alkalization in patients scheduled to undergo chemotherapy by FOLFIRI.3 regimen for colorectal cancer (CRC). METHODS Patients with CRC were randomized 1:1 to a TJ-14 (7.5 g/day) group or an oral alkalization (sodium bicarbonate, 1.8 g/day; ursodeoxycholic acid, 300 mg/day) group. The primary endpoint was incident of late-onset diarrhoea. A total of 30 patients were randomized to either the TJ-14 group or the alkalization group. RESULTS AND DISCUSSION There was no statistical difference in age, concomitantly used drugs or UGT1A1 genotypes between the groups. In the alkalization group (n = 15), the frequency of grade 0/1/2 and grade 3 diarrhoea was 73% and 27%, respectively. In the TJ-14 group (n = 14), the frequency of grade 0/1/2 and grade 3 diarrhoea was 79% and 21%, respectively. Grade 4 diarrhoea was not observed in either group. There was no statistically significant difference in other adverse events or in response to FOLFIRI.3 between the groups. WHAT IS NEW AND CONCLUSION This pilot trial suggests that TJ-14 is a promising alternative treatment option to reduce FOLFIRI.3-induced late-onset diarrhoea, although additional clinical study with a larger number of patients is necessary to confirm these results.
-
8.
Efficacy and safety of Gelsectan for diarrhoea-predominant irritable bowel syndrome: A randomised, crossover clinical trial.
Trifan, A, Burta, O, Tiuca, N, Petrisor, DC, Lenghel, A, Santos, J
United European gastroenterology journal. 2019;(8):1093-1101
-
-
Free full text
-
Abstract
BACKGROUND Irritable bowel syndrome (IBS) is highly prevalent and presents a clinical challenge. Gelsectan is a medical device containing xyloglucan (XG), pea protein and tannins (PPT) from grape seed extract, and xylo-oligosaccharides (XOS), which act together to protect and reinforce the intestinal barrier. OBJECTIVE The objective of this study is to evaluate the efficacy and safety of XG + PPT + XOS in patients with diarrhoea-predominant IBS (IBS-D). METHODS In this double-blind study, 60 patients were randomly assigned to receive XG + PPT + XOS or placebo for 28 days, then crossed over to the alternative treatment. Patients were followed for 60 days. RESULTS At Day 28, a significantly higher proportion of patients starting treatment with XG + PPT + XOS than placebo (87 vs 0%; p = 0.0019) presented normal stools (Bristol Stool Form Scale type 3-4). At Day 56, a significantly higher proportion of patients who crossed over to XG + PPT + XOS than placebo (93% vs 23%; p = 0.0001) presented normal stools. In the group allocated to receive XG + PPT + XOS after placebo, benefits of XG + PPT + XOS were maintained during follow-up. Subjective assessments of abdominal pain, bloating, quality of life and general health indicated significant improvement with XG + PPT + XOS over placebo. There were no related adverse events. CONCLUSION XG + PPT + XOS effectively controlled diarrhoea and alleviated clinical symptoms in patients with IBS-D, and was well tolerated.
-
9.
Randomised clinical trial: pregabalin vs placebo for irritable bowel syndrome.
Saito, YA, Almazar, AE, Tilkes, KE, Choung, RS, Van Norstrand, MD, Schleck, CD, Zinsmeister, AR, Talley, NJ
Alimentary pharmacology & therapeutics. 2019;(4):389-397
-
-
Free full text
-
Abstract
BACKGROUND Pregabalin is a calcium channel α2δ ligand that modifies visceral hypersensitivity in IBS patients. Clinical data for pregabalin in IBS are lacking. AIM: To test the efficacy of pregabalin on gastrointestinal symptoms in IBS patients. METHODS A double-blind, placebo-controlled trial was performed. Adults meeting IBS Rome III criteria with ≥3 pain attacks per month were randomised to pregabalin 225 mg vs placebo twice daily for 12 weeks. Questionnaires were completed weekly. The primary endpoint was average pain Bowel Symptom Scale (BSS) scores weeks 9-12. An intention-to-treat analysis of covariance evaluated treatment effects on quantitative endpoints, adjusting for age and gender. Adequate relief and change in pain score were assessed using a chi-squared test. RESULTS Eighty-five patients were recruited and randomised. Sample characteristics include: mean age 39.4 (SD = 14.6); 73 (86%) female; 37 (44%) IBS-D, 29 (35%) IBS-M, 18 (21%) IBS-C. The pregabalin arm had lower average pain-BSS scores weeks 9-12 (25 vs 42, P = 0.008). Compared with placebo, the overall IBS BSS severity score was lower in the pregabalin arm (26 vs 42, P = 0.009). Differences were observed for the diarrhoea-BSS and bloating-BSS scores (P = 0.049 and 0.016, respectively). No differences between groups were seen for constipation-BSS scores. Adequate relief was not different between the two arms (46% vs 36%, P = 0.35). 63% pregabalin vs 45% placebo had a change in pain score ≥30 at week 12 from baseline (P = 0.10). Post-treatment IBS-QoL scores did not differ between groups. CONCLUSION This trial suggests that pregabalin may be beneficial for IBS abdominal pain, bloating and diarrhoea.
-
10.
Comparison of text messaging data collection vs face-to-face interviews for public health surveys: a cluster randomized crossover study of care-seeking for childhood pneumonia and diarrhoea in rural China.
van Velthoven, MH, Wang, W, Wu, Q, Li, Y, Scherpbier, RW, Du, X, Chen, L, Zhang, Y, Car, J, Rudan, I
Journal of global health. 2018;(1):010802
Abstract
BACKGROUND To compare text messaging and face-to-face interviews to conduct a survey on childhood diarrhoea and pneumonia. METHODS Caregivers of young children able to send text messages in Zhao County in rural China were included in this crossover study. Villages (clusters) were randomized into two groups using the ratio 1:1.6 to account for an expected higher drop-out in group 2. In group 1, participants first completed the face-to-face and then text messaging survey; this order was reversed in group 2. We determined data equivalence of 17 questions that were answered by participants who were the same person in both surveys. For the text messaging survey, we assessed the overall and item response rate. RESULTS We included 1014 participants between 16 and 28 March 2013: 371 in 15 villages in group 1 and 643 in 27 villages in group 2. A total of 662 (65.3%) out of 1014 participants responded (first text message question) and a significantly higher proportion who did not respond were from rural areas (P = 0.005). Of 651 participants willing to participate, 356 (54.7%) completed the text messaging survey, which was marginally significantly different between the groups (P = 0.05). In total, 409 participants took part in both surveys: 183 in group 1 and 226 in group 2. There was a significantly higher proportion of caregivers from rural areas in Zhao County in the non-responder group compared to the responder group (P = 0.004). Kappas were substantial for six (0.61-0.80), moderate for two (0.58 and 0.60), and fair for three questions (0.31, 0.35 and 0.37). The proportion of agreement was >90% for five questions; 80.0%-90.0% for five questions; 70.0%, 65.0% and 45.5%. The remaining questions had too small numbers to calculate these values. CONCLUSIONS This study shows that text messaging data collection produces data similar to data from face-to-face interviews in a middle-income setting, but the response rate was insufficient for use in public health surveys. Improving the response rate is important, because text message surveys could be of greater value in rural remote areas due to the cost-saving potential.