Prebiotic Fructans Effect on 1-3 Years Constipated Children's Bowel Habits

  • STATUS
    Recruiting
  • End date
    Dec 19, 2022
  • participants needed
    100
  • sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Updated on 19 July 2021
maltodextrin
functional constipation

Summary

The aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children.

Description

The aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children. It is a double-blind, randomized, placebo-controlled trial.This study plans to recruit into the group of 100 participants (at least 80 of them completed) in 2018-2020.The two groups for the study are product group (prebiotic fructans) and control group (placebo maltodextrin).Duration of intervention is 6 weeks, including 2 weeks for run-in and 4 weeks for intervention.Efficacy parameters are stool consistency (assessed with Amsterdam infant stool scale),stool frequency, stool amount and stool color (assessed with Amsterdam infant stool scale, treatment success, tolerance and acceptability).

Details
Condition Constipation
Treatment Prebiotic fructans, Non-prebiotic maltodextrin
Clinical Study IdentifierNCT03941925
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Last Modified on19 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of functional constipation following ROME4 criteria
Subject is otherwise healthy at the time of pre-examination
Subject is aged 1-3 years at the time of pre-examination
Subject and caretaker are able and willing to follow the study instructions
Subject 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 mental retardation (Child's mental delay)
Food allergies or intolerances
Using drugs (e.g. antibiotics) influencing gastrointestinal function (4 weeks before run-in, 6 weeks before intervention)
Use of laxatives and labelled pre- and probiotics in the previous 2 weeks before the beginning of run-in (4 weeks before intervention)
Subjects who are currently involved or will be involved in another clinical or food study
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note