NCT04791956

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

March 17, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

3.2 years

First QC Date

March 5, 2021

Last Update Submit

April 11, 2023

Conditions

Infant DevelopmentHealthyDiet, Healthy

Keywords

Microbiota, gastrointestinal health

Outcome Measures

Primary Outcomes (1)

  • Stool consistency

    Assessed by the parents in a continuous daily bowel diary over the study period

    4 weeks

Secondary Outcomes (10)

  • Stool frequency

    4 weeks

  • Stool colour

    4 weeks

  • Stool amount

    4 weeks

  • Sleep

    4 weeks

  • Stool pH

    4 weeks

  • +5 more secondary outcomes

Study Arms (2)

Prebiotic

EXPERIMENTAL

Inulin-type fructans

Dietary Supplement: Prebiotic

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Interventions

PrebioticDIETARY_SUPPLEMENT

Daily intake of Inulin-type fructans from chicory

Prebiotic
PlaceboDIETARY_SUPPLEMENT

Daily intake of maltodextrin

Placebo

Eligibility Criteria

Age6 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitari Sant Joan de Reus - Magatzem

Reus, 43204, Spain

RECRUITING

Hospital Universitari Joan XXIII de Tarragona - Almacén general

Tarragona, 43005, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27931142BACKGROUND

MeSH Terms

Interventions

Prebiotics

Intervention Hierarchy (Ancestors)

Dietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaDietary SupplementsFood and Beverages

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephan Theis, PhD

CONTACT

+49 6359 803 287stephan.theis@beneo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 10, 2021

Study Start

March 17, 2021

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)