Efficacy of Lactobacillus Reuteri Protectis on Functional Abdominal Pain (FAP) in Children 8-14 Years Old (LactoFAP)

The present clinical trial will examine the use of L. reuteri Protectis in children with functional abdominal pain. The aim of the study is to evaluate the use of L. reuteri Protectis on pain (severity and frequency) in children of 8-14 years old and with diagnosis of functional abdominal pain (FAP).

Study Overview

• Status: Terminated
• Conditions: Abdominal Pain
• Intervention / Treatment: Dietary supplement: L. reuteri protectis; Dietary supplement: Placebo tablet

Detailed Description

Subject will be asked to consume a tablet every day for 4 weeks. Supplementation will be stopped after 4 weeks, and the subjects will be followed up for an additional 4 weeks. The subjects will complete a diary to record frequency and intensity of pain, use of medication, deviation from the usual diet, physical activities, and absence from school and other activities. Gastrointestinal symptoms are assessed.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20162
    • AO Niguarda Ca' Granda
  • Milano, Italy, 201442
    • AO "San Paolo"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• FAP (Functional Abdominal Pain) according to Rome III criteria for
• Child/Adolescent (Rasquin, 2006);
• 1 or more abdominal pain episodes per week over the past 8 weeks;
• Informed consent by study participant and at least one parent / legal guardian;
• Age 8-14 years;
• Pain severity at study entry must be at least 40 mm on a 100 mm VAS scale;
• Ability to understand and comply with the requirements of the trial;
• Stated availability throughout the study period.

Exclusion Criteria:

• Chronic illness;
• Surgery of Gastrointestinal tract;
• Any organic symptoms and/or clinical signs of disorder or disease other than FAP;
• Weight loss of 5% or more in body weight over the preceding 3 months;
• Any abnormal result of laboratory assays, also including screening for celiac disease, lactose intolerance;
• Exposure to any drug or medication (antidepressants, SSRIs, laxatives) in the past 3 months or regular use of this medication;
• Exposure to probiotics or antibiotics within 4 weeks prior to study; subjects can be included following a wash-out period of 4 weeks.
• Participation in other clinical trials in the past 3 months;
• Subjects with anemia;
• Subjects with special dietary needs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: L. reuteri protectis tablets; one tablet a day for 4 weeks	Dietary supplement: L. reuteri protectis; 1 tablet once daily for 4 weeks
PLACEBO_COMPARATOR: Placebo tablet; one tablet a day for 4 weeks	Dietary supplement: Placebo tablet; 1 tablet once daily for 4 weeks; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoint	Pain frequency measured by a subject diary, in the L. reuteri Protectis group and the placebo group, expressed as area under the pain-frequency curve and comparing L. reuteri Protectis vs. placebo over the 4-week supplementation period.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary endpoint	Pain frequency measured by subject diary and expressed as area under the curve, comparing L. reuteri protectis vs. placebo over the initial 2 weeks of the supplementation period. Pain severity measured by the face score system by Wong-Baker at day 14, 28 and 56 (follow up) vs baseline, and area under the curve for weeks 1-4 and 1-2. Treatment success, defined as ≥ 50% reduction in pain frequency in weeks 1-4. Reduction in days of absence from school. Parents' absence from work. Need of rescue medication.	56 days

Collaborators and Investigators

• Sponsor: BioGaia AB
• Collaborators: Sprim CRO, Italia
• Investigators: Principal Investigator: Costantino DeGiacomo, MD, Niguarda hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: December 19, 2011
• First Submitted That Met QC Criteria: December 21, 2011
• First Posted (ESTIMATE): December 23, 2011

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain
• Other Study ID Numbers: Q-PRE-0111-CLI-018