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The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation

Primary Purpose

Functional Constipation

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Magnesium Oxide
MIYAIRI-BM
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Constipation

Eligibility Criteria

6 Months - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Rome III Diagnostic Criteria for functional constipation for children aged 6 months - 4 years old is as the following:

  1. Two or fewer defecations per week.
  2. At least one episode per week of incontinence after acquiring toileting skills.
  3. History of excessive stool retention.
  4. History of painful or hard bowel movements.
  5. Presence of a large fecal mass in the rectum.
  6. History of large-diameter stools that may obstruct the toilet. Children aged 6 months - 4 years old is evaluated as functional constipation if two of the situations mentioned above lasted for one month.

Rome III Diagnostic Criteria for functional constipation for children aged 4 years old and above is as the following:

  1. Two or fewer defecations in the toilet per week.
  2. At least one episode of fecal incontinence per week.
  3. History of retentive posturing or excessive volitional stool retention.
  4. History of painful or hard bowel movements.
  5. Presence of a large fecal mass in the rectum.
  6. History of large diameter stools that may obstruct the toilet. Children aged 4 years old and above is evaluated as functional constipation if two of the situations mentioned above happens at least once per week

Exclusion Criteria:

  1. gastroesophageal reflux disease
  2. inflammatory bowel disease
  3. cardiopulmonary diseases
  4. liver disease
  5. renal disease
  6. genetic diseases
  7. endocrinal diseases
  8. received abdominal surgeries

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Magnesium oxide and MIYAIRI-BM

    Magnesium oxide

    Healthy Children

    Arm Description

    Magnesium oxide 125 mg twice per day for children with weight < 15 kg, 250 mg twice per day for weight <15-30 kg, and 500 mg twice per day for weight > 30 kg for 12 weeks. MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight < 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight > 30 kg for 12 weeks.

    MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight < 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight > 30 kg for 12 weeks.

    Healthy Children

    Outcomes

    Primary Outcome Measures

    Change of Clostridium Butyricum Miyairi Expression After Probiotics Supplementation in Constipated Children.
    The expression of Clostridium butyricum Miyairi (CBM) in constipated children feces means a better outcome measure.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 17, 2017
    Last Updated
    July 28, 2019
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03054805
    Brief Title
    The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation
    Official Title
    The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To compare the differences of fecal microflora between constipated and non-constipated healthy children, and evaluate the efficacy of probiotics in reducing symptoms of constipation and the influence of intestinal microflora in children with functional constipation.
    Detailed Description
    The investigators performed a monocentric, prospective, randomized controlled trial including 120 pediatric patients (aged 6 months - 10 years old) with functional constipation and 30 healthy age-matched healthy children as control. The investigators shall evaluate the children according to the Rome III Diagnostic Criteria for functional constipation. The 120 enrolled patients are randomized in to two groups: Group A receiving magnesium oxide and probiotics (MIYAIRI-BM), Group B receiving only magnesium oxide. Each patient is assigned the evaluation constipation symptoms and detection of microflora (beneficial and harmful bacteria) in fecal samples at the enrollment, 4 weeks, and 12 weeks. Patients who take less than 80% of the appropriate dose of medications are withdrawn from the study. All patients included in the study will be given informed oral consent before entering the study. The data of the fecal microflora evaluated in 60 healthy children are used as control.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Functional Constipation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    153 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Magnesium oxide and MIYAIRI-BM
    Arm Type
    Experimental
    Arm Description
    Magnesium oxide 125 mg twice per day for children with weight < 15 kg, 250 mg twice per day for weight <15-30 kg, and 500 mg twice per day for weight > 30 kg for 12 weeks. MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight < 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight > 30 kg for 12 weeks.
    Arm Title
    Magnesium oxide
    Arm Type
    Active Comparator
    Arm Description
    MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight < 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight > 30 kg for 12 weeks.
    Arm Title
    Healthy Children
    Arm Type
    No Intervention
    Arm Description
    Healthy Children
    Intervention Type
    Drug
    Intervention Name(s)
    Magnesium Oxide
    Other Intervention Name(s)
    MgO
    Intervention Description
    Magnesium oxide 250 mg per day for children with weight < 15 kg, 500 mg per day for weight <15-30 kg, and 1000 mg per day for weight > 30 kg
    Intervention Type
    Drug
    Intervention Name(s)
    MIYAIRI-BM
    Other Intervention Name(s)
    Clostridium Butyricum MIYAIRI
    Intervention Description
    MIYAIRI-BM 1 g (1package) per day for children with weight < 15 kg, 2g per day for weight 15-30 kg, and 3g per day for weight > 30 kg
    Primary Outcome Measure Information:
    Title
    Change of Clostridium Butyricum Miyairi Expression After Probiotics Supplementation in Constipated Children.
    Description
    The expression of Clostridium butyricum Miyairi (CBM) in constipated children feces means a better outcome measure.
    Time Frame
    Change from baseline Clostridium butyricum Miyairi expression at 3 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Rome III Diagnostic Criteria for functional constipation for children aged 6 months - 4 years old is as the following: Two or fewer defecations per week. At least one episode per week of incontinence after acquiring toileting skills. History of excessive stool retention. History of painful or hard bowel movements. Presence of a large fecal mass in the rectum. History of large-diameter stools that may obstruct the toilet. Children aged 6 months - 4 years old is evaluated as functional constipation if two of the situations mentioned above lasted for one month. Rome III Diagnostic Criteria for functional constipation for children aged 4 years old and above is as the following: Two or fewer defecations in the toilet per week. At least one episode of fecal incontinence per week. History of retentive posturing or excessive volitional stool retention. History of painful or hard bowel movements. Presence of a large fecal mass in the rectum. History of large diameter stools that may obstruct the toilet. Children aged 4 years old and above is evaluated as functional constipation if two of the situations mentioned above happens at least once per week Exclusion Criteria: gastroesophageal reflux disease inflammatory bowel disease cardiopulmonary diseases liver disease renal disease genetic diseases endocrinal diseases received abdominal surgeries

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation

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