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

NCT ID: NCT01498666

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-04-30

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.

Conditions

Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

L. reuteri protectis tablets

one tablet a day for 4 weeks

Group Type: EXPERIMENTAL

L. reuteri protectis

Intervention Type: DIETARY_SUPPLEMENT

1 tablet once daily for 4 weeks

Placebo tablet

one tablet a day for 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo tablet

Intervention Type: DIETARY_SUPPLEMENT

1 tablet once daily for 4 weeks

Interventions

L. reuteri protectis

1 tablet once daily for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo tablet

1 tablet once daily for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Placebo

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sprim CRO, Italia

UNKNOWN

Sponsor Role: collaborator

BioGaia AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Costantino DeGiacomo, MD

Role: PRINCIPAL_INVESTIGATOR

Niguarda Hospital

Locations

AO Niguarda Ca' granda

Milan, , Italy

AO "San Paolo"

Milan, , Italy

Countries

Italy

Other Identifiers

Q-PRE-0111-CLI-018

Identifier Type: -

Identifier Source: org_study_id