Probiotic Mix for Kids with Irritable Bowel Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates whether a probiotic combination of Lactobacillus rhamnosus GG and Lactobacillus plantarum 299V can improve symptoms, bowel habits, and quality of life in pediatric IBS patients aged 4–18. Participants are randomized to receive the probiotic mix or a placebo, with outcomes including abdominal pain, stool patterns, and gut microbiota changes. The trial is conducted in Italy under the coordination of the University of Bari in collaboration with the University of Udine and led by Prof. Ruggiero Francavilla. Eligibility requires Rome IV–diagnosed IBS and a minimum average daily pain score during a run-in period, with several exclusion criteria to avoid confounding conditions. The study seeks to expand evidence on probiotic use in pediatric IBS and understand microbiota-related effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Children aged 4-18 years;
* Irritable Bowel Syndrome according to Rome IV criteria
* Average daily pain rate of at least 3 out of 10 VAS met during run-in period •-Written informed consent of parent's/legal tutor and verbal or written assent of the patient based on the minor's maturity

Exclusion Criteria:

* Presence of other gastrointestinal diseases (inflammatory bowel disease, pancreatitis, chronic liver disease, eosinophilic esophagitis, peptic ulcer disease, celiac disease, pseudo-obstruction, small bowel bacterial overgrowth, or Hirschsprung's disease);
* Significant chronic health condition requiring specialty care (e.g., lithiasis, ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic, hematopoietic, renal, endocrine, or metabolic diseases) that could potentially impact the child's ability to participate or confound the results of the study.
* Primary or secondary immunodeficiency;
* Malnutrition;
* History of abdominal surgery in the past 3 months.;
* Chronic or acute infectious diseases (viral, bacterial, parasitic) in progress;
* Rome IV criteria diagnosis of functional constipation.
* Use of probiotics/antibiotics within 4 weeks prior to enrolment;
* Current pregnancy or breastfeeding;
* Psychiatric conditions that reduce compliance with the protocol.

Where it's running

• University Of Bari Aldo Moro
  Bari, Ba, Italy Recruiting
• University of Udine-Pediatric Section
  Udine, Ud, Italy Recruiting
• Pediatria Trambusti
  Bari, Bari, Italy Not yet recruiting

Study contacts

• Study coordinator: Ruggiero Francavilla, Prof
• Email: rfrancavilla@gmail.com
• Phone: 00390805592063

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Vitamin D Supplementation in Children with Irritable Bowel Syndrome

  This study tests whether giving vitamin D to children with IBS and low vitamin D levels can improve their IBS symptoms compared with a placebo.

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• IBS-oriented Crohn's Disease Exclusion Diet versus Low FODMAP Diet for IBS

  This study tests whether an IBS-adapted Crohn's Disease Exclusion Diet (CDED) can better help adults with IBS-D or IBS-M than the low FODMAP diet.

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• How certain FODMAPs affect IBS pain in adults

  This study tests whether adding back specific FODMAP types after a low-FODMAP diet can reveal which ones drive abdominal pain in adults with IBS.

  Recruiting Queen's University · Kingston, Ontario · NCT07688044

• Gut–brain gut study in IBS with anxiety and depression

  This study will compare people with IBS and mood symptoms to healthy volunteers to see if gut bacteria relate to brain function using questionnaires, stool and blood samples, and a brain MRI.

  Recruiting Tang-Du Hospital · Xi'an, Shaanxi · NCT07646834

• Pregabalin for irritable bowel syndrome in adults

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  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07635394

• Probiotic combination for irritable bowel syndrome

  This trial will test whether a daily probiotic capsule lowers symptom severity and affects gut transit time in adults with IBS.

  Recruiting Sahlgrenska University Hospital · Gothenburg · NCT07584278

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.