Bifidobacteria In Children With Abdominal Pain-Associated Functional Gastrointestinal Disorders

PHASE4CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

July 31, 2015

Study Completion Date

September 30, 2015

Conditions
Irritable Bowel SyndromeDyspepsia Chronic
Interventions
DRUG

Mixture of three Bifidobacteria

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.

Trial Locations (1)

80131

"University of Naples Federico II Italy", Naples

All Listed Sponsors
lead

Federico II University

OTHER

NCT02566876 - Bifidobacteria In Children With Abdominal Pain-Associated Functional Gastrointestinal Disorders | Biotech Hunter | Biotech Hunter