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A study to compare safety and efficacy of Lactobacillus Rhamnosus GG (ATCC 51303) for treating Functional Abdominal Pain in children.

Safety and efficacy of Lactobacillus GG (ATCC 51303) in children with functional abdominal pain: A randomised double blinded placebo controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039373
Enrollment
82
Registered
2022-01-13
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: K928- Other specified diseases of the digestive system

Interventions

Intervention1: Lactobacillus Rhamnosus GG (ATCC 51303): 10 billion CFU Once a day, Oral for 4 weeks Control Intervention1: Placebo: 1 gm sachet of sugar powder once a day oral for 4 weeks

Sponsors

Geetanjali Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children has a Functional Abdominal Pain according to the Rome IV (H2d) diagnostic criteria: Must be fulfilled at least 4 times per month and include all of the following: 1. Episodic or continuous abdominal pain that does not occur solely during physiologic events (e.g., eating, menses) 2. Insufficient criteria for irritable bowel syndrome, functional dyspepsia, or abdominal migraine. 3. After appropriate evaluation, the abdominal pain cannot be fully explained by another medical condition. Criteria fulfilled for at least 2 months before diagnosis.

Exclusion criteria

Exclusion criteria: 1. History of any other diagnosed chronic diseases, 2. History of use of probiotics in the previous 2 months, 3. History of any previous abdominal surgery. 4. Children whose parents not willing to give consent.

Design outcomes

Primary

MeasureTime frame
relief in abdominal painTimepoint: at 2,4 and 8 weeks

Secondary

MeasureTime frame
Safety and efficay of Lactobacillus Rhamnosus GGTimepoint: at 2,4 and 8 weeks

Countries

India

Contacts

Public ContactDr Taral Kesharani

Geetanjali Medical College and Hospital

drmandot@yahoo.com9462022900

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026