Probiotic fermentation of milk by Lactiplantibacillus pentosus strain 9D3 and its clinical effects on the constipation-predominant irritable bowel syndrome

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260623002

Enrollment

Registered

2026-06-23

Start date

2025-10-09

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

constipation-predominant irritable bowel syndrome (IBS-C) Irritable bowel syndrome with constipation

Interventions

Lactose-free sterilized milk with added sugar, pectin, vitamins, and artificial flavors ,Lactose-free sterilized milk with added sugar, pectin, vitamins, and artificial flavors fermented with L. pento

Placebo Comparator Other,Active Comparator Other

Placebo milk,Probiotic fermented milk

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed by a doctor with IBS-C and stable symptoms, 2. Both male and female, 20-60 years old, 3. BMI < 29.9 kg/m2, 4. No sepsis or any infection, 5. No underlying diseases such as cancer, diabetes, kidney disease, or liver disease, 6. Not allergic to milk and able to drink yogurt, 7. No history of alcohol consumption or smoking within the 6 months prior to entering the program.

Exclusion criteria

Exclusion criteria: 1. Pregnant, suspected pregnancy (more than 7 days late in menstruation), planning to become pregnant, or breastfeeding, 2. Have a history of inflammatory bowel disease or Celiac disease, 3. Have a history of abdominal or intestinal surgery, 4. Consume probiotic products, such as fermented milk, yogurt, cheese, kimchi, or probiotic supplements, regularly and cannot stop taking them within 2 weeks before the study, 5. Take antibiotics within 1 month before the study.

Design outcomes

Primary

Measure	Time frame
Defecation frequency every visit (Week -2, Week 0, Week 4, Week 6) times per week questionnaire ,Stool consistency every visit (Week -2, Week 0, Week 4, Week 6) Bristol Stool Chart ,IBS severity every visit (Week -2, Week 0, Week 4, Week 6) IBS severity scoring system (IBS-SSS) ,Constipation severity every visit (Week -2, Week 0, Week 4, Week 6) ROME III criteria	—

Secondary

Measure	Time frame
Gut microbiota First visit and the end of the intervention 16s RNA sequencing	—

Countries

Thailand

Contacts

Public ContactSuwapat Kittibunchakul

Institute of Nutrition, Mahidol University

suwapatkt@gmail.com0936641536

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026