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

Primary Purpose

Abdominal Pain

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
L. reuteri protectis
Placebo tablet
Sponsored by
BioGaia AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Pain

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AO "San Paolo"
  • AO Niguarda Ca' granda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

L. reuteri protectis tablets

Placebo tablet

Arm Description

one tablet a day for 4 weeks

one tablet a day for 4 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 19, 2011
Last Updated
May 28, 2021
Sponsor
BioGaia AB
Collaborators
Sprim CRO, Italia
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1. Study Identification

Unique Protocol Identification Number
NCT01498666
Brief Title
Efficacy of Lactobacillus Reuteri Protectis on Functional Abdominal Pain (FAP) in Children 8-14 Years Old
Acronym
LactoFAP
Official Title
Efficacy of Lactobacillus Reuteri Protectis on Functional Abdominal Pain (FAP) in Children 8-14 Years Old
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
The recruitment rate was too slow according to study protocol and agreement.
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioGaia AB
Collaborators
Sprim CRO, Italia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L. reuteri protectis tablets
Arm Type
Experimental
Arm Description
one tablet a day for 4 weeks
Arm Title
Placebo tablet
Arm Type
Placebo Comparator
Arm Description
one tablet a day for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
L. reuteri protectis
Intervention Description
1 tablet once daily for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo tablet
Other Intervention Name(s)
Placebo
Intervention Description
1 tablet once daily for 4 weeks
Primary Outcome Measure Information:
Title
Primary endpoint
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Secondary endpoint
Description
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.
Time Frame
56 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Costantino DeGiacomo, MD
Organizational Affiliation
Niguarda Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AO "San Paolo"
City
Milano
ZIP/Postal Code
201442
Country
Italy
Facility Name
AO Niguarda Ca' granda
City
Milan
ZIP/Postal Code
20162
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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