Prebiotic EffecT InfanTs | NCT04791956

Studies
Prebiotic EffecT InfanTs

NCT04791956

Sponsor

Beneo-Institute

Status

Unknown status

Last Update Posted

Apr 12, 2023Actual

Enrollment

140Estimated

Phase

Not Applicable

Conditions

Infant Development
Healthy
Diet, Healthy

Interventions

Prebiotic
Placebo

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2021Actual

Primary Completion Date

Jun 2024Estimated

Completion Date

Jun 2024Estimated

First Submitted Date

Mar 5, 2021

First Submission Date that Met QC Criteria

Mar 9, 2021

First Posted Date

Mar 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2023

Last Update Posted Date

Apr 12, 2023Actual

Name	Class
Hospital Universitari Sant Joan de Reus	OTHER
Hospital de Tarragona Joan XXIII	UNKNOWN
Institut Investigacio Sanitaria Pere Virgili	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prebiotic	Experimental	Inulin-type fructans	Dietary Supplement: Prebiotic
Placebo	Placebo Comparator	Maltodextrin	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prebiotic	Dietary Supplement	Daily intake of Inulin-type fructans from chicory	Prebiotic

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

12 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stephan Theis, PhD	Contact	+49 6359 803 287		stephan.theis@beneo.com

Overall Officials

Name	Affiliation	Role
Ricardo Closa Monasterolo, Phd, MD	Paediatrics Unit, University Hospital Joan XXIII, Tarragona, Spain. Paediatrics Research Unit on Nutrition and Human Development, Universitat Rovira i Virgili, Reus, Spain	Principal Investigator
Joaquin Escribano Subias, PhD, MD	Paediatrics Unit, University Hospital Sant Joan, Reus, Spain. Paediatrics Research Unit on Nutrition and Human Development, Universitat Rovira i Virgili, Reus, Spain

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitari Sant Joan de Reus - Magatzem	Recruiting	Reus		43204	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27931142	Background	Closa-Monasterolo R, Ferre N, Castillejo-DeVillasante G, Luque V, Gispert-Llaurado M, Zaragoza-Jordana M, Theis S, Escribano J. The use of inulin-type fructans improves stool consistency in constipated children. A randomised clinical trial: pilot study. Int J Food Sci Nutr. 2017 Aug;68(5):587-594. doi: 10.1080/09637486.2016.1263605. Epub 2016 Dec 8.

ID	Term
D004043	Dietary Fiber
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D011135	Polysaccharides, Bacterial