Evaluation of probiotic use in chronic functional constipatio

Phase 3

Recruiting

Conditions: Functional constipation.

Registration Number: IRCT20160117026069N5

Lead Sponsor: Karaj University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Suffering from functional constipation according to Rome IV criteria
Age 2 to 14 years
Enforceability of orders by the child's parents

Exclusion Criteria

Children with organic causes of constipation including celiac disease, intestinal obstruction, hypothyroidism, anorectal malformation, CF
Serious chronic health problems that affect the child's ability to participate in the study, such as metabolic, heart, kidney, and liver diseases
Unwanted weight loss equal to or more than 5% of the current weight during the last three months
Gastrointestinal bleeding
Recurrent or unexplained fever
History of abdominal surgery including gastrointestinal surgery, except for appendix removal or hernia repair
Simultaneous use of drugs that affect the movements of the digestive system
History of increased sensitivity or allergy to experimental drugs
Diagnosis of autism symptoms
Severe mental problems such as bipolar disorder, schizophrenia, and severe depression
Use of (SNS) or antegrade enemas during cecostomy or appendicostomy

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment of functional constipation. Timepoint: The beginning of the study (before the start of the intervention), one week later, week 3, week 5, and week 7. Method of measurement: doctor checkup.;Abdominal pain. Timepoint: The beginning of the study (before the start of the intervention), one week later, week 3, week 5, and week 7. Method of measurement: doctor checkup.;Side effects. Timepoint: The beginning of the study (before the start of the intervention), one week later, week 3, week 5, and week 7. Method of measurement: doctor checkup.;Need for rescue treatment. Timepoint: The beginning of the study (before the start of the intervention), one week later, week 3, week 5, and week 7. Method of measurement: doctor checkup.

Secondary Outcome Measures