Efficacy of Probiotic in the Treatment of Childhood Functional Constipation

Evaluating The Effects of Lactobacillus Sporogenes in Combination with Mineral Oil Compared with Mineral Oil Alone on Symptoms of Constipation in Children aged 2 to 15 Years with Functional Constipation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201207311579N1

Enrollment

Registered

2012-09-11

Start date

2010-01-05

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Childhood Functional Constipation. Constipation

Interventions

Intervention 1: Controls: Mineral oil (Paraffin 1 ml/kg/d) for 8 weeks. Intervention 2: All children: Toilet training and dietary advices. Intervention 3: Intervention: Synbiotic (Lactol®, Bioplus Lif

Lactobacillus Sporogenes (15 × 107 Spores), Fructo-Oligosaccharides, Microcrystalline Cellulose, Sodium starch Glycolate, Povidone, Hypermellose Stearate, Sillicon Dioxide, and Propylene Glycol.

Treatment - Drugs

Behavior

Controls: Mineral oil (Paraffin 1 ml/kg/d) for 8 weeks

All children: Toilet training and dietary advices

Intervention: Synbiotic (Lactol®, Bioplus Life Sciences Pvt. 1 Tab/20kg/d) plus mineral oil (Paraffin 1 ml/kg/d) for 8 weeks. The synbiotic used in this study composed of the followings

Eligibility

Sex/Gender

All

Age

2 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1- Children 2 to 15 years of age, 2- Having functional constipation based on the Rome III criteria, 3- Parents' Consent for Participation. Exclusion Criteria: 1- Those with immunocompromised condition or other severe diseases, 2- Those receiving antibiotic in the previous four weeks, 3- Experiencing severe side effects, gastroenteritis, or receiving antibiotic for any reason during the study period.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Symptoms of constipation. Timepoint: Before and 2 months after treatment. Method of measurement: Rome III questionnaire.	—

Secondary

Measure	Time frame
Global improvement. Timepoint: Two months after treatment. Method of measurement: Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ali Gholamrezaei

Medical Students' Research Center, Isfahan University of Medical Sciences

ali.gholamrezaei.63@gmail.com+98 31 1669 8675

Outcome results

None listed

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