None listed
Conditions
Interventions
None listed
Sponsors
Societe des Produits Nestle S A
Covance India Pharmaceutical Services Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Healthy, to the opinion of the investigator. Fully term (37- 42 weeks of gestation) singleton infant. Postnatal age at least 6 weeks and up to 4 months. Parents as the primary caregiver (i.e., at least 5 out of 7 days per week under parentsâ?? care). Parents at least 18 years old. Exclusively/predominantly breastfeeding or exclusively/predominantly formula feeding of the same type/brand, for at least the past 2 weeks. Evidence of personally signed and dated informed consent document by the infantâ??s parent(s).
Exclusion criteria
Exclusion criteria: Chronic illness necessitating medical follow up. Acute ongoing or recent (last 2 weeks) illness necessitating medical follow up. Any known case of food allergy (e.g., milk). Caregivers who are not likely to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An index score of overall GI symptom burden measured by a validated, standardized Infant Gastrointestinal Symptom Questionnaire (IGSQ-13)Timepoint: There is only one visit for the study. At time of signing of ICF, a research staff member will assist the parents to complete (i) Feeding Practice and Gut Comfort Questionnaire and (ii) the Infant Gastrointestinal Symptom Questionnaire (IGSQ). | — |
Secondary
| Measure | Time frame |
|---|---|
| GI symptoms (stooling, spitting-up/vomiting and flatulence) as well as GI related behaviors (crying and fussiness) collected by the IGSQ-13 (response to individual questions in the questionnaire). Stool characteristics (frequency and consistency) collected via a one-day recall in the Feeding Practice and Gut Comfort Questionnaire. Physician-reported (based on ROME IV diagnosis criteria) and parent-reported colic collected in the Feeding Practice and Gut Comfort Questionnaire.Timepoint: There is only one visit for the study. At time of signing of ICF, a research staff member will assist the parents to complete (i) Feeding Practice and Gut Comfort Questionnaire and (ii) the Infant Gastrointestinal Symptom Questionnaire (IGSQ). | — |
Countries
Egypt, India, Indonesia, Malaysia, Pakistan
Contacts
Public ContactShekhar Dawkhar
Covance India Pharmaceutical Services Private Limited
Outcome results
None listed