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Not yet recruiting NCT07342972

Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula

No phase Interventional Gastrointestinal Tolerance Gastrointestinal Symptoms Infections Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Goat milk-based infant formula, Cow's milk-based infant formula.
Who it may be relevant to
Registry conditions: Gastrointestinal Tolerance, Gastrointestinal Symptoms, Infections, Quality of Life. Basic parameters: 14 Days — 90 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Saudi Arabia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of a Goat-milk Based Infant Formula on Gastrointestinal Symptoms and Tolerability in Healthy Term Infants: a Double-blind Randomized Controlled Trial

Overview

This randomized controlled double-blind study will compare the effect of a commercially available goat milk formula to a cow's milk formula on gastrointestinal symptoms and tolerance, and infections in infants.

Interventions

  • Other Goat milk-based infant formula
    Study product is administered on demand until the age of 6 months.
  • Other Cow's milk-based infant formula
    Study product is administered on demand until the age of 6 months.

Primary outcome measures

  • Gastrointestinal symptoms as determined by CoMiSS [Time frame: Difference between groups at Day 14 of the intervention]
  • Gastrointestinal tolerance as determined by IGSQ [Time frame: Difference between groups at the end of the intervention at 24 weeks]
Secondary outcome measures (12)
  • Gastrointestinal symptoms throughout the study as determined by CoMiSS [Time frame: From enrollment to the end of the intervention at 24 weeks]
  • Gastrointestinal tolerance throughout the study as determined by IGSQ [Time frame: From enrollment to the end of the intervention at 24 weeks]
  • Occurrence, duration and severity of gastrointestinal infections as determined by Vesikari [Time frame: From enrollment to the end of the intervention at 24 weeks]
  • Occurrence, duration and severity of respiratory infections as determined by CARIFS [Time frame: From enrollment to the end of the intervention at 24 weeks]
  • Occurrence, duration and severity of ear infections as determined by AOM-SOS V5 [Time frame: From enrollment to the end of the intervention at 24 weeks]
  • Quality of life as determined by PedsQL [Time frame: From enrollment to the end of the intervention at 24 weeks]
  • Quality of life as determined by WHOQoL-BREF [Time frame: From enrollment to the end of the intervention at 24 weeks]
  • Weight [Time frame: From enrollment to the end of the intervention at 24 weeks]
  • Height [Time frame: From enrollment to the end of the intervention at 24 weeks]
  • Head circumference [Time frame: From enrollment to the end of the intervention at 24 weeks]
  • WHO z-scores [Time frame: From enrollment to the end of the intervention at 24 weeks]
  • Fecal parameters [Time frame: Baseline, Day 14, Day 28, Week 12 and Week 24]

Eligibility criteria

Inclusion criteria

  • Age between 14 days and 90 days.
  • Healthy singleton term infants born between 37 weeks and 42 weeks of gestation.
  • Infants who have received CMF for at least 7 consecutive days.
  • Exclusive formula feeding.
  • Cow's Milk-related Symptoms Score (CoMiSS®) value at baseline of ≥6 and <10.
  • Parents' or caregivers, aged ≥18 years, willing to give informed consent and adhere to study protocol

Exclusion criteria

  • Exclusively or partially feeding with human milk
  • Introduced to solid food, supplementary feeding, use of pre- and/or probiotics as a supplement
  • Congenital or recurrent chronic conditions and/or malabsorption that could interfere with study parameters.
  • Diagnosed cow's milk allergy (CMA) or suspected to have CMA, soy allergy, fish allergy, egg allergy and/or lactose intolerance.
  • Receiving medication (on own initiative or prescription) with regard to FGID (i.e. reflux medication)
  • Sibling already participating in this study
  • Participation in another clinical trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Saudi Arabia · 1 center
  • King Faissal Specialist Hospital & Research Centre — Riyadh

Identifiers

NCT: NCT07342972 · P24-150

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗