Efficacy of Probiotic in the Treatment of Childhood Functional Constipatio

Phase 3

Conditions: Childhood Functional Constipation.
Constipation

Registration Number: IRCT201207311579N1

Lead Sponsor: Vice chancellor for research, Islamic Azad University, Najafabad Branch

Brief Summary: Background: Functional constipation is one of the most prevalent childhood gastrointestinal disorders. We evaluated effects of adding a probiotic to mineral oil in the treatment of functional constipation in children.<br /> Materials and Methods: This controlled trial was conducted on 60 children (2 to 14 years old) with functional constipation (Rome III criteria). Children were allocated to receive the synbiotic (Lactol®, composed of Lactobacillus Sporogenes, 1 Tab/20kg/d) plus mineral oil (Paraffin 1 ml/kg/d) or the mineral oil alone for two months. Symptoms of constipation including defecation frequency, stool form, strain and pain at defecation, incomplete evacuation and soiling were assessed and compared before and after the intervention. After the treatment period, the two groups were also compared with regards to subjective global improvement.<br /> Results: After the treatment, stool frequency increased in both groups (P < 0.001), with greater increase in synbiotic + mineral oil group (P = 0.001). Frequency of hard/very hard stool and frequency of painful defecation decreased similarly in both groups (P < 0.001). Straining at defecation, incomplete evacuation, and soiling decreased in both groups (P < 0.001), but more decrease was seen in the synbiotic + mineral oil group (P < 0.05). Finally, there was a better global improvement in the synbiotic + mineral oil group (P < 0.05). No severe side effects were observed in any group.<br /> Conclusion: Adding the synbiotic Lactol® (containing Lactobacillus Sporogenes) to mineral oil can increase the improvement in children constipation symptoms without specific side effects.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 60

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.