Treatment of Chronic Constipation in Children With Lactobacillus Reuteri

NCT ID: NCT01629147

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-09-30

Brief Summary

Lactobacillus reuteri (Biogaia) may be beneficial for treatment of chronic constipation in children 4-10 years of age.

Detailed Description

Functional chronic constipation is very common in childhood and is responsible for 20% of the clinic visits in pediatric gastroenterology. Constipation is defined by the Rome III criteria. The symptoms are difficult to treat in part of the patients and cause frustration to the patient and family.

Probiotics are increasingly used in the treatment of functional gastrointestinal disorders, including chronic constipation in adults and children. A recent study revealed that the administration of Lactobacillus reuteri had a positive effect on bowel frequency in infants with chronic constipation.

The study goal is to evaluate Lactobacillus reuteri (Biogaia) for treatment of chronic constipation in children 4-10 years of age, and to examine the influence of Lactobacillus reuteri (Biogaia) on constipation in different age groups of school aged children between 4-10 yrs of age.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Biogaia

5 drops containing Lactobacillus reuteri Protectis

Group Type: EXPERIMENTAL

Biogaia

Intervention Type: DIETARY_SUPPLEMENT

5 drops containing Lactobacillus reuteri Protectis

Placebo

\- 5 drops identical in appearance and taste

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

5 drops

Interventions

Biogaia

5 drops containing Lactobacillus reuteri Protectis

Intervention Type: DIETARY_SUPPLEMENT

Placebo

5 drops

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients 4-10 years old with no underlying chronic illnesses or anatomical abnormalities of the GI tract, with parents agreeing to participate in the study and signing an informed consent.

2. Chronic constipation defined by the Rome III criteria (Must include 2 or more of the following in a child with a developmental age of at least 4 years with insufficient criteria for diagnosis of IBS: 1. Two or fewer defecations in the toilet per week. 2. At least 1 episode of fecal incontinence per week. 3. History of retentive posturing or excessive volitional stool retention. 4. History of painful or hard bowel movements. 5. Presence of a large fecal mass in the rectum. 6. History of large diameter stools that may obstruct the toilet).

3. Normal Thyroid function test and negative celiac serology (IgA or IgG in patients with IgA deficiency), and no evidence of elevated RAST test for milk.

4. Parents or tutors signed informed consent to the child's participation the study.

5. Willingness to comply with the protocol.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Batia Weiss

Director, Division of Pediatric Gastroenterology and Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sheba medical center

Ramat Gan, Tel Hashomer, Israel

Asaf Harofe medical center

Zrifin, , Israel

Countries

Israel

Central Contacts

Batia Weiss, MD

Role: CONTACT

weissb@sheba.health.gov.il

972526666315

Facility Contacts

Batia Weiss, MD

Role: primary

weissb@sheba.health.gov.il

972526666315

Efrat Broide, MD

Role: primary

efibroide@yahoo.com

Other Identifiers

SHEBA-11-8960-BW-CTIL

Identifier Type: -

Identifier Source: org_study_id