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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06274242
• Other study ID #: MU-CIRB 2022/300.0711
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 10, 2023
• Est. completion date: April 19, 2024

Study information

• Verified date: February 2024
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: April 19, 2024
• Est. primary completion date: July 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation

Intervention

Dietary Supplement:
• Haruna
Mixed Natural Prebiotic-Fibers (Ginkgo nut, Spinach, Corn, Brown rice)
• Placebo Powder
Isolate Soy Protein and Isomalt

Locations

Country	Name	City	State
Thailand	Mahidol University	Nakhon Pathom

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Stool Frequency	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).	12 weeks
Primary	Change in Fecal Microbiota	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.	12 weeks
Secondary	Change in Stool consistency	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.	12 weeks