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

Mahidol University

Status: Active, not recruiting

Conditions: Constipation

Treatments: Dietary Supplement: Haruna; Dietary Supplement: Placebo Powder

Study type: Interventional

Funder types: Other

Identifiers

NCT06274242

MU-CIRB 2022/300.0711

Details and patient eligibility

About

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

Enrollment: 98 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups, including a placebo group

Prebiotic arm

Experimental group

Treatment:

Dietary Supplement: Haruna

Placebo arm

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo Powder