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出境医 / 临床实验 / Prebiotic Fructans Effect on 1-3 Years Constipated Children's Bowel Habits (CONSTICHILD)

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

Study Description
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).
Study Design
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
Arms and Interventions
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.
Outcome Measures
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.


Eligibility Criteria
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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
Contacts and Locations

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
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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
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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
Tracking Information
First Submitted Date  ICMJE May 6, 2019
First Posted Date  ICMJE May 8, 2019
Last Update Posted Date September 3, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019) 		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)
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019) 		Stool consistency [ Time Frame: 4 weeks ]
The primary variable is the stool consistency during the last two weeks of product consumption.Tables including descriptive statistics (N, arithmetic mean, standard deviation, minimum, median, maximum), p-values for the treatment effect and 95% confidence for the treatment difference will be prepared.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • Stool frequency [ Time Frame: 4 weeks ]
    Assessed by daily parental reporting.
  • 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)
  • Treatment success [ Time Frame: 4 weeks ]
    ROME IV criteria still met at the end of the intervention.
  • 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.
  • Faecal Short Chain Fatty Acids concentration [ Time Frame: 4 weeks ]
    Change in Short Chain Fatty Acids over a four week period.
  • Faecal pH [ Time Frame: 4 weeks ]
    Change in faecal pH over a four week period.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Stool frequency [ Time Frame: 4 weeks ]
    Change in stool frequency over a four week period
  • Stool amount and stool colour [ Time Frame: 4 weeks ]
    Change in amount and stool colour over a four week period
  • Treatment success [ Time Frame: 4 weeks ]
    Change in diagnosis criteria over a four week period
  • Faecal microbiota [ Time Frame: 4 weeks ]
    Change in faecal microbiota over a four week period
  • faecal SCFA concentration [ Time Frame: 4 weeks ]
    Change in SCFA over a four week period
  • Faecal pH [ Time Frame: 4 weeks ]
    Change in faecal pH over a four week period
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prebiotic Fructans Effect on 1-3 Years Constipated Children's Bowel Habits
Official Title  ICMJE 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
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Constipation
Intervention  ICMJE
  • Dietary Supplement: Prebiotic fructans
    Prebiotic group receiving the prebiotic fructans in two doses during the 4-week intervention period.
  • Dietary Supplement: Non-prebiotic maltodextrin
    Placebo group receiving the non-prebiotic maltodextrin in two doses during the 4-week intervention period.
Study Arms  ICMJE
  • Experimental: Prebiotic fructans
    Prebiotic fructans. Prebiotic will be mixed into foods or drinks and consumed twice daily.
    Intervention: Dietary Supplement: Prebiotic fructans
  • Placebo Comparator: Maltodextrin
    Maltodextrin. Maltodextrin will be mixed into foods or drinks and consumed twice daily.
    Intervention: Dietary Supplement: Non-prebiotic maltodextrin
Publications * Closa-Monasterolo R, Ferré 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 6, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 3 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941925
Other Study ID Numbers  ICMJE XH-18-016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study Sponsor  ICMJE Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators  ICMJE Beneo GmbH
Investigators  ICMJE
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
PRS Account Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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