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Preventive effect of synbiotic supplement on infant colic

Preventive effects of synbiotic oral supplementation on infant colic: a prospective randomized clinical trial study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230123057193N2
Enrollment
102
Registered
2024-03-14
Start date
2024-04-19
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Infant Colic. Other and unspecified abdominal pain

Interventions

Intervention 1: Intervention group: The intervention group will receive 10 drops of synbiotic supplement daily for 8 weeks. This supplement is purchased from bio-fermentation company under the brand n

Sponsors

Research assistant of Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Days to 10 Days

Inclusion criteria

Inclusion criteria: Having a birth age of 37 to 42 weeks Birth weight above 2000 grams Refer to the clinic under 10 days old The health of the baby in terms of physical examinations

Exclusion criteria

Exclusion criteria: Taking antibiotics and probiotics before starting the study Any need for initial hospitalization or readmission Congenital defects, immunity, metabolic and growth and development Allergy to gluten, cow's milk protein or any substance in placebo or synbiotic syrup and lactose intolerance Any known abdominal pain Participation in any other intervention Probiotic consumption by mothers

Design outcomes

Primary

MeasureTime frame
Colic disease Incidence. Timepoint: The beginning of the intervention (before the start of the intervention), 4 weeks after the intervention and 8 weeks after the intervention. Method of measurement: Based on Rome 4 (ROM IV) criteria and doctor's diagnosis.

Secondary

MeasureTime frame
Calprotectin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Fecal quantities using a special kit.;Mother's quality of life. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ???????? SF36.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Sadat Fahimzad

Tehran University of Medical Sciences

f.fahimzad@gmail.com+98 21 6648 1731

Outcome results

None listed

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