Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 226 for:    Intestinal | maltodextrin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03941925
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : September 2, 2019
Sponsor:
Collaborator:
Beneo GmbH
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

Condition or disease Intervention/treatment Phase
Constipation Dietary Supplement: Prebiotic fructans Dietary Supplement: Non-prebiotic maltodextrin Not Applicable

Detailed 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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized Placebo-controlled Trial Investigating the Effect of Prebiotic Fructans on Bowel Habits of Constipated Young Children One to Three Years of Age
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prebiotic fructans
Prebiotic fructans. Prebiotic will be mixed into foods or drinks and consumed twice daily.
Dietary Supplement: Prebiotic fructans
Prebiotic group receiving the prebiotic fructans in two doses during the 4-week intervention period.

Placebo Comparator: Maltodextrin
Maltodextrin. Maltodextrin will be mixed into foods or drinks and consumed twice daily.
Dietary Supplement: Non-prebiotic maltodextrin
Placebo group receiving the non-prebiotic maltodextrin in two doses during the 4-week intervention period.




Primary Outcome Measures :
  1. Stool consistency [ Time Frame: 4 weeks ]
    Assessed by the parents in a continuous daily bowel diary over the study period using the Amsterdam Infant Stool Scale (AISS) comprised of a 4-point scale (A: watery, B: soft, C: formed, D: hard)


Secondary Outcome Measures :
  1. Stool frequency [ Time Frame: 4 weeks ]
    Assessed by daily parental reporting.

  2. Stool amount and stool colour [ Time Frame: 4 weeks ]
    Assessed by the parents in a continuous daily bowel diary over the study period using the Amsterdam Infant Stool Scale (AISS). Stool amount will be assessed on a 4-point scale (1: smear, 2: up to 25%, 3: 25.50%, 4: >50%, relative to diaper surface). Stool colour will be assessed on a 6-point scale (I: yellow, II: orange, III: green, IV: brown, V: meconium, VI: clay-coloured)

  3. Treatment success [ Time Frame: 4 weeks ]
    ROME IV criteria still met at the end of the intervention.

  4. Faecal microbiota [ Time Frame: 4 weeks ]
    Stool samples will be analyzed by appropriate molecular biological methods like 16S rRNA gene sequencing to gain insight into the composition of the gut microbiota. Furthermore, metabolites like SCFA and other organic acids will be measured with appropriate chromatographic methods.

  5. Faecal Short Chain Fatty Acids concentration [ Time Frame: 4 weeks ]
    Change in Short Chain Fatty Acids over a four week period.

  6. Faecal pH [ Time Frame: 4 weeks ]
    Change in faecal pH over a four week period.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of functional constipation following ROME4 criteria.
  2. Subject is otherwise healthy at the time of pre-examination.
  3. Subject is aged 1-3 years at the time of pre-examination.
  4. Subject and caretaker are able and willing to follow the study instructions.
  5. Subject is suitable for participation in the study according to the investigator/physician/study personnel.
  6. Written informed consent is given by parent or legal guardian.

Exclusion Criteria:

  1. No legal guardian`s command of any local language.
  2. Organic causes of defecation disorders incl. Hirschsprung disease, Spina bifida, hypothyroidism etc.
  3. Other metabolic or renal abnormalities or mental retardation (Child's mental delay).
  4. Food allergies or intolerances.
  5. Using drugs (e.g. antibiotics) influencing gastrointestinal function (4 weeks before run‐in, 6 weeks before intervention).
  6. Use of laxatives and labelled pre‐ and probiotics in the previous 2 weeks before the beginning of run‐in (4 weeks before intervention)
  7. Subjects who are currently involved or will be involved in another clinical or food study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941925


Contacts
Layout table for location contacts
Contact: Wei Cai, Doctor 021-25078674 ext 021-25078674 caiw1978@163.com
Contact: Weihui Yan, Doctor 021-25078674 ext 021-25078674 yanweihui1982@sina.com

Locations
Layout table for location information
China
Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine
Shanghai, China
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Beneo GmbH
Investigators
Layout table for investigator information
Principal Investigator: Wei Cai, Doctor Xin Hua Hospital,School of Medicine, Shanghai Jiaotong University
Study Director: Weihui Yan, Doctor Xin Hua Hospital,School of Medicine, Shanghai Jiaotong University
Study Chair: Ying Wang, Doctor Xin Hua Hospital,School of Medicine, Shanghai Jiaotong University
Study Chair: Lina Lu, Doctor Xin Hua Hospital,School of Medicine, Shanghai Jiaotong University
Study Chair: YIjing Tao Xin Hua Hospital,School of Medicine, Shanghai Jiaotong University
Study Chair: Haixia Feng Xin Hua Hospital,School of Medicine, Shanghai Jiaotong University
Study Chair: Yinghong Chen Xin Hua Hospital,School of Medicine, Shanghai Jiaotong University
Study Chair: Anna Li Xin Hua Hospital,School of Medicine, Shanghai Jiaotong University

Publications:
Layout table for additonal information
Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03941925     History of Changes
Other Study ID Numbers: XH-18-016
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
prebiotic
Additional relevant MeSH terms:
Layout table for MeSH terms
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Levan
Antineoplastic Agents