Prebiotic EffecT InfanTs (PETIT)

Beneo

Status: Enrolling

Conditions: Healthy; Infant Development; Diet, Healthy

Treatments: Dietary Supplement: Prebiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04791956

20018m-jhr

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 6 to 12 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Prebiotic

Experimental group

Description:

Inulin-type fructans

Treatment:

Dietary Supplement: Prebiotic

Placebo

Placebo Comparator group

Description:

Maltodextrin

Treatment:

Dietary Supplement: Placebo