Using probiotics to treat abdominal pain in children
The Effects of Probiotics, Lactobacillus GG, in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders - A Randomized Controlled Trial
This study is testing if a probiotic called Lactobacillus GG can help children aged 6-15 with stomach pain feel better and improve their quality of life.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 6 Years to 15 Years |
| Sex | All |
| Sponsor | Prince of Songkla University Academic / other |
| Locations | 1 site (Songkhla) |
| Trial ID | NCT06310733 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Lactobacillus GG, a type of probiotic, on children aged 6-15 who suffer from functional abdominal pain disorders, such as irritable bowel syndrome. The study aims to determine whether this probiotic can alleviate symptoms and improve the quality of life for these children. Participants will be divided into two groups, receiving either the probiotic or a placebo, to assess the effectiveness of the treatment. The trial is designed to provide insights into the role of the microbiome in managing abdominal pain in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6-15 diagnosed with irritable bowel syndrome or functional abdominal pain according to the Rome IV criteria.
Not a fit: Patients with chronic diseases, recent antibiotic or probiotic use, or those showing alarming signs of organic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce abdominal pain and improve the quality of life for children suffering from functional abdominal pain disorders.
How similar studies have performed: Previous studies have shown promising results with probiotics in managing gastrointestinal symptoms, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children, aged 6-15 years old, with a diagnosis of IBS or FAP, according to the Rome IV diagnostic criteria. The diagnosis of IBS or FAP was based on a clinical interview performed by pediatric gastroenterologist. For healthy controls: non-obese children, aged 6-15 years old, without any gastrointestinal symptoms at the time of recruitment. Exclusion Criteria: * Children who 1. had any chronic diseases, including neurobehavioral disorders 2. received treatment with antibiotics/probiotics in the previous 2 months 3. received medication that affects gastrointestinal motility in the previous 1 week 4. had a pain history suggestive of functional dyspepsia/aerophagia/abdominal migraine/functional constipation 5. exhibited growth failure 6. had gastrointestinal obstructions/stricture 7. displayed alarming signs of organic condition 8. had previous abdominal surgery 9. had abnormal baseline test results as part of their standard work-up (e.g. complete blood counts; erythrocyte sedimentation rate; liver-pancreas-kidney function tests; stool examination for occult blood, ova, and parasites; fecal calprotectin; urinalysis; abdominal ultrasound; 13C-urea breath test; gastric emptying study, if any) 10. had family history of peptic ulcer disease or inflammatory bowel disease
Where this trial is running
Songkhla
- Atchariya Chanpong — Songkhla, Thailand (Recruiting)
Study contacts
- Study coordinator: Atchariya Chanpong, M.D, Ph.D.
- Email: atchariya.c@psu.ac.th
- Phone: 6674451250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.