RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Experimental arm: probiotic for Irritable Bowel Syndrome (IBS)

This clinical study aims to see if 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).

Official registry: https://clinicaltrials.gov/study/NCT07125625 · University of Bari · enrollment listed as 124

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Experimental arm: probiotic, or Placebo. The registry lists allocation as randomized. This clinical study aims to see if a specific combination of probiotics-Lactobacillus rhamnosus GG and Lactobacillus plantarum 299V-can help children and adolescents with Irritable Bowel Syndrome (IBS).

They plan to enroll about 124 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Randomized Double Blind Placebo Controlled Trial on a Probiotic Mixture (L. Rhamnosus GG Plus L. Plantarum 299V) in Pediatric Irritable Bowel Syndrome: Clinical Efficacy and Multiomics Approach

Interventions: Experimental arm: probiotic, Placebo

Primary outcome (registry wording): VAS visual analogue scale 0-10

Who it is for (from inclusion criteria)

Ages 4 Years to 18 Years
Children aged 4-18 years;
Irritable Bowel Syndrome according to Rome IV criteria

Who the registry excludes

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);
Primary or secondary immunodeficiency;
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;

Public study contact (from the registry)

Ruggiero Francavilla, Prof

00390805592063

rfrancavilla@gmail.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

3 listed

Pediatria Trambusti — Bari, Bari, Italy (not_yet_recruiting)
University Of Bari Aldo Moro — Bari, BA, Italy (recruiting)
University of Udine-Pediatric Section — Udine, UD, Italy (recruiting)

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland

Von Hippel-Lindau (VHL): Clinical Manifestations, Diagnosis, Management and Molecular Bases of Inherited Re…

We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled.

NCT00001238 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

RecruitingNot a traditional drug phaseBethesda, Maryland

Study of Systemic Lupus Erythematosus

This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.

NCT00001372 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

RecruitingNot a traditional drug phaseWashington D.C., District of Columbia

Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics

This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.

NCT00001373 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)

FAQ about this NCT record

Is NCT07125625 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07125625?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07125625?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary