Prebiotic EffecT InfanTs

Study Overview
=================
Brief Summary
-----------------
The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on stool consistency in infants.

Detailed Description
-----------------
The fermentation of prebiotic inulin-type fructans leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA). The introduction of solid foods is frequently associated with harder stools which are more difficult to pass and can cause painful defecations. Subsequently, the changes in bowel habits associated with weaning and the introduction of complementary foods could be minimized by the addition of prebiotics to complementary foods and, thus, the transition from milk-feeding to family food could be facilitated.

Official Title
-----------------
Double-blind, Randomized Placebo-controlled Trial Investigating the Effect of Prebiotic Inulin-type Fructans on Bowel Habits of Infants

Conditions
-----------------
Infant Development, Healthy, Diet, Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Prebiotic
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child is healthy at the time of pre-examination Child was born on term or preterm (≥ 32 weeks of gestation) Child is aged 6-12 months at the time of pre-examination (for preterm born children (32-37 weeks of gestation), corrected age will be applied) Normal growth (weight and length for age between 10th and 90th percentiles, Fenton and Kim 2013) Child receives at least one meal per day as complementary feeding Child and legal guardian are able and willing to follow the study instructions Child is suitable for participation in the study according to the investigator/physician/study personnel Written informed consent is given by parent or legal guardian Exclusion Criteria: No legal guardian's command of any local language Organic causes of defecation disorders incl. Hirschsprung disease, Spina bifida, hypothyroidism etc. Other metabolic or renal abnormalities or psychomotor retardation (e.g. hypotonia) Child has allergy to cow's milk protein or lactose intolerance Child has been or is currently breast-fed more than once daily (6 weeks before intervention) Child has mostly loose or watery stools in ≥ 50% of defecations Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention) Use of laxatives or pre- or probiotic supplements in the previous 4 weeks before intervention Child is currently involved or will be involved in another clinical or food study

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prebiotic<br>Inulin-type fructans | Dietary Supplement: Prebiotic<br>* Daily intake of Inulin-type fructans from chicory<br>|
| Placebo Comparator: Placebo<br>Maltodextrin | Dietary Supplement: Placebo<br>* Daily intake of maltodextrin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool consistency | Assessed by the parents in a continuous daily bowel diary over the study period | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool frequency | Assessed by daily parental reporting | 4 weeks | 
| Stool colour | Assessed by the parents in a continuous daily bowel diary over the study period | 4 weeks | 
| Stool amount | Assessed by the parents in a continuous daily bowel diary over the study period | 4 weeks | 
| Sleep | Change in sleep behavior assessed by parental questionnaire (Brief Infant Sleep Questionnaire) at the beginning and end of the trial | 4 weeks | 
| Stool pH | change in stool pH over a four week period | 4 weeks | 
| stool short-chain fatty acids | change in amount and relative distribution of short-chain fatty acids in stool over a four week period | 4 weeks | 
| Tolerance and acceptability | Tolerance and acceptability of the study products assessed by customized parental questionnaire at the end of the trial | 4 weeks | 
| Body weight | changes in body weight (kg) assessed by an investigator | 4 weeks | 
| Body height | changes in body height (m) assessed by an investigator | 4 weeks | 
| Faecal Microbiota | Stool samples will be analysed by appropriate molecular biological methods like 16S rRNA gene sequencing to gain insight into the composition of the gut microbiota. | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microbiota, gastrointestinal health