Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults

Not Applicable

Active, not recruiting

• Conditions: Constipation
• Interventions: Dietary Supplement: Placebo Powder; Dietary Supplement: Haruna

• Registration Number: NCT06274242
• Lead Sponsor: Mahidol University

Brief Summary

Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-10
• Primary Completion: 2023-07-22
• Status Verified: 2024-02
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-22
• Last Update Submitted: 2024-02-22
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23
• Study Completion: 2024-04-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Healthy adults with a Body mass index (BMI) of 16.00 to 29.99 kg/m2
• Self-reported constipation according to the Rome IV criteria

Exclusion Criteria

• Pregnancy
• Crohn's disease or any other inflammatory bowel disease
• Pelvic floor dyssynergia
• Have congenital diseases such as liver disease, diabetes, and thyroid dysfunction. hypercalcemia neurological disease
• Drink alcohol or smoke regularly.
• During the past 1 month or while in the project, have received antibiotics, steroids, NSAIDs, blood pressure-lowering drugs, antidepressants, anticonvulsants, or Parkinson's disease medications
• History of food allergy to Haruna's ingredients
• There has been a change in body weight (increase or decrease of 5 kilograms over a period of 6 months).
• During the past 2 weeks or while in the project, have received probiotics or other prebiotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	Placebo Powder	-
Prebiotic arm	Haruna	-

Primary Outcome Measures

Name	Time	Method
Change in Fecal Microbiota	12 weeks	Change in Bifidobacterium relative abundance with 2log ratio of relative abundance, during the intervention period, compared between prebiotic arm and placebo arm. Subjects with an increase in Bifidobacterium relative abundance were considered to have a good response.
Change in Stool Frequency	12 weeks	Stool frequency during the intervention period was determined by modified Constipation scoring system using questionnaire with the following variables: frequency of bowel movements; painful evacuation effort; feeling of incomplete evacuation; abdominal pain; minutes in lavatory per attempt; type of assistance; unsuccessful attempts for evacuation. This consists of six items that are scored using a five-point Likert scale that ranges from 0 (none of the time) to 4 (all of the time) and one item that is rated on a 0-2 scale. A total score can range from 0 (normal) to 26 (severe constipation).

Secondary Outcome Measures

Name	Time	Method
Change in Stool consistency	12 weeks	Stool consistency during the intervention period was determined by Bristol stool scale score using questionnaire with the following scale score: 1, separate hard lumps, like nuts; 2, sausage-shaped but lumpy; 3, like a sausage but with cracks on its surface; 4, like a sausage or snake, smooth and soft; 5, soft blobs with clear-cut edges; 6, fluffy pieces with ragged edges, a mushy stool; 7, watery, no solid pieces. 1-2 scale indicate constipation. 3-4 scale are ideal stools as they are easier to pass. 5-7 scale may indicate diarrhea and urgency.

Trial Locations

Locations (1)

Mahidol University; 🇹🇭 Nakhon Pathom, Thailand