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

NCT01498666 | Terminated

• 1 other identifier: Q-PRE-0111-CLI-018
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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).

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary endpoint

  56 days

Study Arms (2)

L. reuteri protectis tablets

EXPERIMENTAL

one tablet a day for 4 weeks

Dietary Supplement: L. reuteri protectis

Placebo tablet

PLACEBO COMPARATOR

one tablet a day for 4 weeks

Dietary Supplement: Placebo tablet

Interventions

L. reuteri protectis DIETARY_SUPPLEMENT

1 tablet once daily for 4 weeks

L. reuteri protectis tablets

Placebo tablet DIETARY_SUPPLEMENT

1 tablet once daily for 4 weeks

Also known as: Placebo

Placebo tablet

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• FAP (Functional Abdominal Pain) according to Rome III criteria for
• Child/Adolescent (Rasquin, 2006);
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BioGaia AB: lead
• Sprim CRO, Italia: collaborator

Study Sites (2)

AO Niguarda Ca' granda

Milan, 20162, Italy

Location

AO "San Paolo"

Milan, 201442, Italy

Location

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Costantino DeGiacomo, MD

  Niguarda Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: December 23, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 2, 2021

Record last verified: 2013-12

Locations

IT (2)