Gastrointestinal Diseases Clinical Trial
Official title:
Clinical Trial to Assess Improvement of Digestive Symptoms With Goat's Milk Infant Formula.
NCT number | NCT06301139 |
Other study ID # | P17-004 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2019 |
Est. completion date | February 1, 2024 |
Verified date | March 2024 |
Source | Ausnutria Hyproca B.V. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, the investigators aim to assess that infants with mild symptoms have significantly less (severe) symptoms after 14 days goat milk-based formula use compared to infants using cow's milk-based formula supplemented with probiotic drops.
Status | Completed |
Enrollment | 18 |
Est. completion date | February 1, 2024 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Weeks to 3 Months |
Eligibility | Inclusion Criteria: - Healthy full-term infant with birth weight =2,500 to =4,500 g - Infant aged between 4 weeks and 3 months at enrolment - CoMiSS value at baseline between 6 and 12 - Infant is exclusively bottle fed with cow's milk based infant formula at baseline Exclusion Criteria: - Breastfed infants - Congenital illness or malformation that may affect infant feeding or normal growth - Gastrointestinal disorders - Confirmed cow or goat milk protein allergy or lactose intolerance - Supplemental feeding - Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrolment - Infant participating in another clinical study |
Country | Name | City | State |
---|---|---|---|
Spain | HM hospitales | Madrid |
Lead Sponsor | Collaborator |
---|---|
Ausnutria Hyproca B.V. | HM hospitales |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cow's Milk-related Symptoms | Difference in Cow's Milk related Symptom Score (CoMiSS: score ranges from 0 to 33 with higher scores indicating more symptoms) at baseline and after 14 days of intervention. | 0-2 weeks | |
Secondary | Cow's Milk-related Symptoms | Difference in Cow's Milk-related Symptoms Score (CoMiSS: score ranges from 0 to 33 with higher scores indicating more symptoms) at baseline and after 28 days of intervention. | 0-4 weeks | |
Secondary | Parental stress | Difference in parental stress measured by Parental Stress Index-Short Form (PSI-SF: score ranges from 15% to 100% with higher scores indicating more stress) at baseline, after 5 days, after 9 days and after 28 days of intervention. | 0-4 weeks | |
Secondary | Parental quality of life | Difference in parental quality of life measured by World Health Organization Quality Of Life questionnaire - short version (WHOQOL-BREF: score ranges from 0 to 100 with higher scores indicating better quality of life ) at baseline, after 5 days, after 9 days and after 28 days of intervention. | 0-4 weeks | |
Secondary | Weight | Difference in weight (grams) at baseline, after 14 days and after 28 days of intervention. | 0-4 weeks | |
Secondary | Length | Difference in length (cm) at baseline, after 14 days and after 28 days of intervention. | 0-4 weeks | |
Secondary | Weight-for-age | Difference in weight-for-age z-scores calculated using the World Health Organization Child Growth Standards at baseline, after 14 days and after 28 days of intervention. | 0-4 weeks | |
Secondary | Length-for-age | Difference in length-for-age z-scores calculated using the World Health Organization Child Growth Standards at baseline, after 14 days and after 28 days of intervention. | 0-4 weeks | |
Secondary | Weight-for-length | Difference in weight-for-length z-scores calculated using the World Health Organization Child Growth Standards at baseline, after 14 days and after 28 days of intervention. | 0-4 weeks |
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