Evaluation of probiotic use in chronic functional constipation

Evaluation of probiotic use (Lactobacillus reuteri) in children between ages of 2 and 14 with chronic functional constipation; Double-blind randomized clinical trial.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160117026069N5

Enrollment

Registered

2023-01-26

Start date

2023-01-21

Completion date

Unknown

Last updated

2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional constipation.

Interventions

Intervention 1: Pidrolax drug (Pidrolax 4000 powder, 70g packets, made by Sepidaj Daru Company) is prescribed according to the following method: Children's dose 2 to 6 years old: 5 grams (one tablespo

Eligibility

Sex/Gender

All

Age

2 Years to 14 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFereshteh Ansari

Razi Vaccine and Serum Research Institute

fereshtehansari66@gmail.com+98 26 3405 0400

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026