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The comparison of the efficacy of two different synbiotics in the treatment of infantile functional constipation

The comparison of the efficacy of a synbiotic containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus”(Pedilact drop) with a synbiotic containing “Bifidobacterium lactis"(BB care drop) in the treatment of infantile functional constipation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160827029535N7
Enrollment
80
Registered
2020-02-22
Start date
2020-02-09
Completion date
Unknown
Last updated
2020-03-24

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

Conditions

Infantie functional constipation. Other diseases of intestines

Interventions

Intervention 1: Group A intervention: They will recieve nonpharmacological treatment +a synbiotic containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus”(Pedilact

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Must include 1 month of at least 2 of the following in infants up to 4 years of age:1.Two or fewer defecations per week 2.History of excessive stool retention 3. History of painful or hard bowel movements 4. History of large-diameter stools 5. Presence of a large fecal mass in the rectum

Exclusion criteria

Exclusion criteria: GI Obstraction or previous GI surgery ; Recieving opiates, muscle relaxants and sedatives ; Mechanical ventilation; Underlying diseases, Central and Pripheral nervous system diseases ; Irritable bowel syndrome ;Endocrine Diseases( Hypothyroidism) ; anorectal abnormalities; recieving probiotics products since one week before intervention

Design outcomes

Primary

MeasureTime frame
Response rate of clinical manifestations of infantile constipation to each synbiotic in each group. Timepoint: One week and one month after beginning of intervention. Method of measurement: Questionnaire according to the new Rome IV criteria.

Secondary

MeasureTime frame
Complications of each drug ( diarrhea, vomiting and skin rush) during intervention. Timepoint: One week and one month after intervention. Method of measurement: Questionnaire according to the occurance of diarrhea, vomiting and skin rush.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPeymaneh Alizadeh Taheri

Tehran University of Medical Sciences

p.alizadet@yahoo.com+98 21 7301 3420

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 10, 2026