Bifidobacteria In Children With Abdominal Pain-Associated Functional Gastrointestinal Disorders

NCT02566876 | Completed Phase 4 DMC

• 1 other identifier: 02122013
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Abdominal pain (AP)-associated functional gastrointestinal disorders (FGIDs), particularly Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), are common in pediatrics, and no safe and effective treatment is available. Although probiotics have shown promising results in adults, few studies have been published in children. The Bifidobacterium Infantis, Bifidobacterium Breve and Bifidobacterium Longum are the most important beneficial bacteria in children and represent 95% of the total bacterial population in the intestine of breastfed infant. Objectives: 1) To evaluate the effect of oral administration of a mixture of Bifidobacteria on the improvement of frequency and intensity of AP in children with FD and IBS. 2) To evaluate the effect of oral administration of a mixture of Bifidobacteria on quality of life in children with FD and IBS.

Conditions

Irritable Bowel Syndrome; Dyspepsia Chronic

Keywords

Children; Abdominal Pain; Functional Dyspepsia; Irritable Bowel Syndrome; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Abdominal Pain Frequency

  Score ranges from 0 (never) to 5 (every day)

  16 weeks from the enrollment

Secondary Outcomes (1)

• Functional Disability

  16 weeks from the enrollment

Study Arms (2)

Mixture of three Bifidobacteria

ACTIVE COMPARATOR

Patients were administered 1 sachet per day of a mixture of three Bifidobacteria (namely, 3 billions of Bifidobacterium longum BB536®, 1 billion of Bifidobacterium infantis M-63®, and 1 billion of Bifidobacterium breve M-16V®) for six weeks. Subsequently, no preparation was administered for a 2-week-''washout'' period. At each follow-up visit subjects underwent a complete physical examination, data recorded on the daily diaries were collected and compliance to treatment was verified.

Drug: Mixture of three Bifidobacteria

Placebo

PLACEBO COMPARATOR

Patients were administered 1 sachet per day of placebo for six weeks. Subsequently, no preparation was administered for a 2-week-''washout'' period. At each follow-up visit subjects underwent a complete physical examination, data recorded on the daily diaries were collected and compliance to treatment was verified.

Drug: Mixture of three Bifidobacteria

Interventions

Mixture of three Bifidobacteria DRUG

This investigation will be a randomized, double-blind, placebo-controlled, cross-over trial. The study will include 70 children with FD or IBS and will be articulated in 16 weeks as follows. Fifty-nine children (median age 11.2 years, range 5.2-17.9) with IBS and FD were randomized to receive either a mixture of three Bifidobacteria or a placebo for 6 weeks. At the end, after a 2-week-''washout'' period, each patient was switched to the other group and followed for 6 further weeks. At baseline and at follow-up, patients and/or their parents completed a dairy for bowel habit and gastrointestinal symptoms, and a quality of life (QoL) questionnaire.

Also known as: Bifidobacterium infantis M-63® breve M-16V® longum BB536®

Mixture of three Bifidobacteria; 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:

• Age 4-18years;
• Diagnosis of FD and IBS pain according to the Rome III criteria
• All parents or legal tutors must sign an informed consent document indicating their awareness of the investigational nature of this study.

You may not qualify if:

• Taking any other type of probiotic in the 2 months prior to enrollment
• Presence of intestinal motility disorders
• Presence of any other significant medical condition
• Presence of previous abdominal surgery
• Inability or unwillingness to give informed consent

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples "Federico II" Italy

Naples, 80131, Italy

Location

Related Publications (1)

• Giannetti E, Maglione M, Alessandrella A, Strisciuglio C, De Giovanni D, Campanozzi A, Miele E, Staiano A. A Mixture of 3 Bifidobacteria Decreases Abdominal Pain and Improves the Quality of Life in Children With Irritable Bowel Syndrome: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial. J Clin Gastroenterol. 2017 Jan;51(1):e5-e10. doi: 10.1097/MCG.0000000000000528.

  PMID: 27306945 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Eleonora Giannetti, MD

  Department of Translational Medical Sciences, Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: October 2, 2015
• Study Start: December 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 2, 2015

Record last verified: 2015-09

Locations

IT (1)