1. Digestive tolerability and acceptability of Fibersol-2 in healthy and diarrheal children 1–3 years old at a rural facility, Bangladesh: Results from a four arm exploratory study
- Author
-
Abu Sadat Mohammad Sayeem Bin Shahid, Shahnawaz Ahmed, Tanzina Tazul Renesa, Anindita Tasnim Onni, Sampa Dash, Yuka Kishimoto, Sumiko Kanahori, Tahmeed Ahmed, Abu Syed Golam Faruque, and Mohammod Jobayer Chisti
- Subjects
Diarrhea ,Rural Population ,Bangladesh ,Multidisciplinary ,Child, Preschool ,Drinking Water ,Humans ,Infant ,Child ,Abdominal Pain - Abstract
Background Fibersol-2 has some beneficial effects on human health. We aimed to evaluate the digestive tolerability and acceptability of Fibersol-2 in healthy and diarrheal children, as well as improvement in stool consistencies in young diarrheal children. Methods Sixty children of either sex, aged 1–3 years having four groups (healthy children/low dose, healthy children/high dose, children with diarrhea/low dose and children with diarrhea/high dose) were enrolled into this exploratory study between 1st August to 23rd October 2017. Two presumptive doses, low (2.5g) and high (5g), twice daily with 50 ml drinking water for seven days were the interventions. Outcomes were to observe the development of possible abdominal symptoms, such as pain, distension, rumbling, and bloating during the intervention and post-intervention periods in healthy and diarrheal children as well as improvement in stool consistencies in diarrheal children. Results Among the diarrheal children, the median (IQR) duration of resolution of diarrhea was 3.9 (2.9, 5.1) days vs. 3.5 (2.0, 8.0) days, p = 0.885; in low dose and high dose groups, respectively. Significant difference was observed in terms of abdominal pain (27% vs. 7%, p = 0.038) and distension (40% vs. 0%, p Conclusion Fibersol-2 was found to be well tolerated in healthy and diarrheal children aged 1–3 years. Trial registration This study was registered as part of a randomized trial at ClinicalTrials.gov, number NCT03565393. The authors confirmed that all ongoing and related trials for this drug/intervention were registered.
- Published
- 2022