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

NCT03054805 | Completed Phase 4 Results

• 1 other identifier: 103-0519A3
• Study Type: interventional
• Target: 153
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Functional Constipation

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline Clostridium butyricum Miyairi expression at 3 months.

Study Arms (3)

Magnesium oxide and MIYAIRI-BM

EXPERIMENTAL

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.

Drug: Magnesium Oxide; Drug: MIYAIRI-BM

Magnesium oxide

ACTIVE COMPARATOR

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.

Drug: Magnesium Oxide

Healthy Children

NO INTERVENTION

Healthy Children

Interventions

Magnesium Oxide DRUG

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

Also known as: MgO

Magnesium oxide; Magnesium oxide and MIYAIRI-BM

MIYAIRI-BM DRUG

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

Also known as: Clostridium Butyricum MIYAIRI

Magnesium oxide and MIYAIRI-BM

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• gastroesophageal reflux disease
• inflammatory bowel disease
• cardiopulmonary diseases
• liver disease
• renal disease
• genetic diseases
• endocrinal diseases
• received abdominal surgeries

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Interventions

Magnesium Oxide

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Dr. Hsun-Chin Chao
• Organization: Chang Gung Memorial Hospital

chaohero@yahoo.com

88633281200

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: February 16, 2017
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2016
• Last Updated: August 14, 2019
• Results First Posted: August 14, 2019

Record last verified: 2014-09

Data Sharing

• IPD Sharing: Will not share