The Use of Lactobacillus Reuteri in Functional Constipation in Children

Functional Constipation Clinical Trial

Official title:

The Use of Lactobacillus Reuteri in Functional Constipation in Children: A Double Blind Randomized Control Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03333070
• Other study ID #: 0042-17-EMC
• Status: Terminated
• Phase: N/A
• Start date: June 26, 2018
• Est. completion date: June 26, 2018

Study information

• Verified date: October 2018
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Functional constipation (FC) is a common condition in childhood, with an estimated prevalence of 0.7% to 29%.The diagnosis and treatment of FC can be difficult tasks, and children are often referred to specialist services causing treatment to become expensive and time-consuming.The standard treatment based on osmotic laxatives (mainly PEG). The recovery rate is 50% to 60% after 1 year of treatment, with 50% of the children having relapse within 5 years. Studies in adults have established the effectiveness of some lactic acid bacteria in the treatment of chronic constipation.

Description:

Functional constipation (FC) is a common condition in childhood, with an estimated prevalence of 0.7% to 29%.The diagnosis and treatment of FC can be difficult tasks, and children are often referred to specialist services causing treatment to become expensive and time-consuming.The standard treatment based on osmotic laxatives (mainly PEG). The recovery rate is 50% to 60% after 1 year of treatment, with 50% of the children having relapse within 5 years. Studies in adults have established the effectiveness of some lactic acid bacteria in the treatment of chronic constipation.However, it is unclear whether similar effects occur in children. Lactobacilli and Bifidobacteria are the most studied species showing a high safety profile. Both are able to promote colonic peristalsis which could be beneficial for the treatment of constipation .Even though traditional treatment is well established and safe, high proportion of children need prolonged treatment for several months or even years. For many parents there is a concern regarding prolonged treatment with PEG .Lactobacilli, bifidobacteria and FOS (fructooligosaccharide) increase stool frequency and decrease consistency in healthy adults and therefore could prevent recurrence of constipation after PEG withdrawal .The principle investigator hypothesize that treatment with probiotics adjunct to PEG and several months thereafter could decrease the proportion of children needed permanent or prolonged treatment (>12 months) with PEG.

The importance of the study and its practical benefits:

Treatment with PEG for FC is well established and is considered safe. Despite that, a high proportion of children need prolonged treatment for several months or even years. For many parents there is a concern regarding prolonged treatment with PEG. Previous studies did not demonstrate efficacy of treatment with probiotics or prebiotics in FC. Neither of these studies assessed effectiveness probiotics/prebiotic products as adjunct to the traditional treatment (PEG) of FC in shortening its period.

A recently published studies including from Israel, demonstrated efficacy of Lactobacillus reuteri in irritable bowel syndrome, infantile colic and functional abdominal pain .Therefore, demonstration of positive effect of treatment with probiotic product in FC, could imply for potential use of this product in other functional gastrointestinal disorders among children.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: June 26, 2018
• Est. primary completion date: June 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 15 Years

Eligibility

Inclusion Criteria:

• Age 0.5 - 15 years

• Diagnosis of functional constipation according to Rome IV criteria

Exclusion Criteria:

• Children with chronic diseases which could cause constipation: Celiac disease, food allergy, Hypothyroidism, Inflammatory Bowel Disease, electrolytes disturbances, Cystic fibrosis, Hirschsprung disease, Neuropathic conditions (Spinal cord trauma, Neurofibromatosis, Tethered cord) or intestinal pseudo-obstruction.

• Prematurity (< 34 weeks)

• S/P intestinal surgery

• Children treated with medications associated with constipation.

• Existing malignancy

• Primary or secondary immunodeficiency

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

Dietary Supplement:
• probiotic - Lactobacillus reuteri
The treated arm will receive 5 drops per day for 48 weeks

Other:
• placebo - with no active ingredient
The control arm will receive 5 drops per day for 48 weeks

Locations

Country	Name	City	State
Israel	Emek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of constipation recurrence	according to Rome IV criteria	This measure will be assessed at weeks 24.
Primary	The prevalence of constipation recurrence	according to Rome IV criteria	This measure will be assessed at weeks 60.
Primary	failure of maintaining normal bowel movements without PEG and the need to resume PEG treatment	according to Rome IV criteria	This measure will be assessed at weeks 24.
Primary	failure of maintaining normal bowel movements without PEG and the need to resume PEG treatment	according to Rome IV criteria	This measure will be assessed at weeks 60.
Secondary	The number of bowel movements per week	The investigator will collect the information during the following visits from the patient	This measure will be assessed at baseline and at 24, 36, 48 and 60 weeks after enrolment
Secondary	The number of episodes of fecal incontinence per week	The investigator will collect the information during the following visits from the patient	This measure will be assessed at baseline and at 24, 36, 48 and 60 weeks after enrolment
Secondary	The stool consistency in patients without PEG treatment	The investigator will collect the information during the following visits from the patient	This measure will be assessed at baseline and at 24, 36, 48 and 60 weeks after enrolment