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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Constipation
• Intervention / Treatment: Dietary supplement: Haruna; Dietary supplement: Placebo Powder

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Nakhon Pathom, Thailand, 73170
    • Mahidol university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo arm	Dietary supplement: Placebo Powder; Isolate Soy Protein and Isomalt
Experimental: Prebiotic arm	Dietary supplement: Haruna; Mixed Natural Prebiotic-Fibers (Ginkgo nut, Spinach, Corn, Brown rice)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Sirirat Luk-in, phD, Department of Clinical Microbiology and Applied Technology, Faculty of Medical Technology, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Actual): July 22, 2023
• Study Completion (Estimated): April 19, 2024

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: MU-CIRB 2022/300.0711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the publication of this research project.
• IPD Sharing Time Frame: After the publication of this research project.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No