Probiotic Mixture (L. Rhamnosus GG and L. Plantarum 299V) In Pediatric Irritable Bowel Syndrome

NCT07125625 | Not Yet Recruiting

• 1 other identifier: PRIME
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

What is this study about? This clinical study aims to investigate whether a specific combination of probiotics-Lactobacillus rhamnosus GG and Lactobacillus plantarum 299V-can help children and adolescents with Irritable Bowel Syndrome (IBS). IBS is a common digestive condition in children, causing abdominal pain, bloating, and changes in bowel habits (either diarrhoea, constipation, or alternating between the two). These symptoms can seriously affect a child's daily life and wellbeing. The study is coordinated by the University of Bari, in collaboration with the University of Udine, and led by Prof. Ruggiero Francavilla. Why is this study being done? Although probiotics are increasingly used in IBS, solid scientific evidence in children is still limited. This study will assess whether the chosen probiotic mix improves symptoms, bowel habits, and quality of life in young people with IBS. It will also investigate how the probiotics affect gut bacteria (microbiota) and the chemicals produced by the body (metabolomics), to better understand how these changes might help relieve symptoms. Who can take part? Children and adolescents aged 4 to 18 years with a diagnosis of IBS (based on international Rome IV criteria) who experience abdominal pain on a daily basis. Children with other significant medical conditions, recent surgery, or ongoing infections, as well as those taking antibiotics or other probiotics shortly before the study, cannot participate. How does the study work? The study is a randomised, double-blind, placebo-controlled trial, meaning that some children will receive the probiotic drops, and others will receive placebo drops (which do not contain probiotics), and neither the participants nor the doctors will know who is receiving which treatment. This is the best way to test whether the probiotics really work. Each participant will be involved in the study for about 14 weeks, divided into: A 2-week "run-in" period to confirm eligibility. An 8-week treatment period (probiotic or placebo). A 4-week follow-up. The probiotics/placebo are taken as 20 drops once daily for 8 weeks. Throughout the study, children and parents will be asked to keep a daily diary of abdominal pain and bowel habits, and to complete validated questionnaires on symptom severity and quality of life. Stool and urine samples will also be collected at different time points to analyse changes in gut bacteria and body metabolism. What are the aims of the study? Primary aim: To see whether the probiotics reduce abdominal pain by at least 30% compared to the start of the study. Secondary aims: To check if bowel habits improve (stool consistency and frequency). To assess improvements in quality of life. To analyse whether the probiotics cause positive changes in gut bacteria and metabolic profiles. To ensure that the treatment is safe and well-tolerated. What are the possible risks and benefits? The probiotic mixture used in this study has been studied in children before and is generally considered safe. The study includes careful monitoring for any side effects. Participants may or may not experience an improvement in symptoms. However, the information gained from the study will help doctors better understand how probiotics work in IBS and may benefit future patients. What are participants' rights? Participation is voluntary, and families may withdraw their child from the study at any time, without affecting the child's medical care. The study has been approved by an independent ethics committee and complies with all European and Italian regulations regarding research in children. All personal data and medical information will be treated confidentially and securely, in accordance with privacy laws. Where is the study taking place? The study is being conducted at the Paediatric Gastroenterology Unit of the University of Bari Aldo Moro and the Paediatric Unit of the University of Udine. These centres are national referral centres for children with gastrointestinal problems. Who is funding and organising the study? The study is sponsored and conducted by the University of Bari. The probiotic and placebo products are provided by Dicofarm S.p.A., who also ensures that the placebo and probiotic products look and taste the same to maintain the study's blinding.

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

food supplement; probiotics; irritable bowel syndrome

Outcome Measures

Primary Outcomes (1)

• VAS visual analogue scale 0-10

  Treatment success defined as decrease of abdominal pain severity of at least 30% from baseline (measured with VAS).

  BASELINE AND AFTER 4 WEEKS

Secondary Outcomes (4)

• Bristol Stool Form Scale

  BASELINE AND AFTER 4 WEEKS

• Change in Quality of life

  BASELINE AND AFTER 4 WEEKS

• Irritable Bowel Syndrome Symptom Severity Score

  BASELINE AND AFTER 4 WEEKS

• Microbiota

  BASELINE AND AFTER 4 WEEKS

Study Arms (2)

Probiotic

EXPERIMENTAL

62 children will take the product under study based on One capsule/sachet containing L. Rhamnosus GG 1x10\^10 CFU plus L. Plantarum 299V 1x10\^10 CFU per day for 8 weeks

Dietary Supplement: Experimental arm: probiotic

Placebo

PLACEBO COMPARATOR

62 children will take a carbohydrate-based control product (maltodextrin)

Dietary Supplement: Placebo

Interventions

Experimental arm: probiotic DIETARY_SUPPLEMENT

a dietary supplement containing L. Rhamnosus GG 1x1010 CFU plus L. Plantarum 299V. 1x1010 CFU

Probiotic

Placebo DIETARY_SUPPLEMENT

Placebo (maltodextrine)

Placebo

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Pediatria Trambusti

Bari, bari, 70100, Italy

Location

Related Publications (16)

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MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Ruggiero Francavilla, Prof

CONTACT

00390805592063; rfrancavilla@gmail.com

fernanda Cristofori, MD

CONTACT

00393384176598; fernandacristofori@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Nobody knows the randomization code
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized double bind with placebo

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: August 15, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

IT (1)