Study on the Effect of Inulin in Infant Formula on Gut Health

Study Overview
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Brief Summary
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In this study the effect of Infant formula with added Inulin will be compared with the effect of Infant formula without Inulin on the Bifidobacterium level in stool. It is expected that drinking Infant formula with added Inulin will result in higher beneficial bacteria level in stool compared to an Infant formula without Inulin.

Official Title
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A Randomized, Double-blind, Controlled Study on the Effect of Inulin on Gut Health of Infants

Conditions
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Healthy Infants

Intervention / Treatment
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* Other: Powder based infant formula
* Other: Powder based infant formula
* Other: Powder based infant formula


Participation Criteria
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Eligibility Criteria
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Inclusion criteria at screening: Healthy infants between 3-4 months (91-120 days after birth) of age at day 1 of the study, with healthy growth determined based on WHO standard Fully formula-fed in the 28 days prior to inclusion Expected investigational product intake of min 500ml per day Written informed consent from the parents Exclusion criteria at screening: Low birth weight (LBW) less than 2,000g. Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special toddler formula is required) Use of systemic antibiotics or antimycotics medication in the 14 days prior to the study Significant congenital abnormality that will interfere with the study objectives in the opinion of the investigator. Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study. Exclusion criteria for intervention period: Not consuming study product longer than 2 days consecutively Intake of study product is less than 500ml per day for 7 days

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group I<br>Intervention group I: Powder based Infant formula with Inulin I | Other: Powder based infant formula<br>* Powder based infant formula with Inulin I<br>|
| Experimental: Intervention group II<br>Intervention group II: Powder based Infant formula with Inulin II | Other: Powder based infant formula<br>* Powder based infant formula with Inulin II<br>|
| Placebo Comparator: Intervention group III<br>Intervention group III: Powder based Infant formula without Inulin | Other: Powder based infant formula<br>* Powder based infant formula without Inulin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between beneficial bacteria I level in stool at week 4 and week 8. |  | Week 4, Week 8. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between beneficial bacteria II level in stool at week 4 and week 8. |  | Week 4, Week 8. | 
| Difference between pH of stool at week 4 and week 8. |  | Week 4, Week 8. | 
| Difference between stool consistency at week 4 and week 8. |  | Week 4, Week 8. | 
| Difference between sIgA at week 4 and week 8. |  | Week 4, Week 8. | 
| Difference between SCFA at week 4 and week 8. |  | Week 4, Week 8. | 
| Safety and tolerability. | The safety and tolerability achieved by continuous recording of adverse events, including the occurrence of diarrhea and constipation. | From date of baseline visit (day 1) until the date of visit 8 (day 56) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy infants, Infant formula, Prebiotics