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

NCT06274242 | Active Not Recruiting

• 1 other identifier: MU-CIRB 2022/300.0711
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Constipation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Change in Stool consistency

  12 weeks

Study Arms (2)

Prebiotic arm

EXPERIMENTAL

Dietary Supplement: Haruna

Placebo arm

PLACEBO COMPARATOR

Dietary Supplement: Placebo Powder

Interventions

Haruna DIETARY_SUPPLEMENT

Mixed Natural Prebiotic-Fibers (Ginkgo nut, Spinach, Corn, Brown rice)

Prebiotic arm

Placebo Powder DIETARY_SUPPLEMENT

Isolate Soy Protein and Isomalt

Placebo arm

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Mahidol University

Nakhon Pathom, 73170, Thailand

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sirirat Luk-in, phD

  Department of Clinical Microbiology and Applied Technology, Faculty of Medical Technology, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 23, 2024
• Study Start: March 10, 2023
• Primary Completion: July 22, 2023
• Study Completion: April 19, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the publication of this research project.

Locations

TH (1)