Trial Outcomes & Findings for The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation (NCT NCT03054805)

Results Overview

The expression of Clostridium butyricum Miyairi (CBM) in constipated children feces means a better outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

153 participants

Primary outcome timeframe

Change from baseline Clostridium butyricum Miyairi expression at 3 months.

Results posted on

2019-08-14

Participant Flow

This trial is expected to recruit 180 children, but the actual willingness to participate in the trial is 153 children.

Participant milestones

Participant milestones
Measure	Magnesium Oxide and MIYAIRI-BM 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. Magnesium Oxide: 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 MIYAIRI-BM: 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	Magnesium Oxide 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. Magnesium Oxide: 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	Healthy Children Healthy children without any treatment
Overall Study STARTED	58	51	44
Overall Study COMPLETED	42	41	42
Overall Study NOT COMPLETED	16	10	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Magnesium Oxide and MIYAIRI-BM n=42 Participants 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. Magnesium Oxide: 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 MIYAIRI-BM: 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	Magnesium Oxide n=41 Participants 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. Magnesium Oxide: 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	Healthy Children n=42 Participants Healthy children without any treatment	Total n=125 Participants Total of all reporting groups
Age, Categorical <=18 years	42 Participants n=5 Participants	41 Participants n=7 Participants	42 Participants n=5 Participants	125 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	2.75 years STANDARD_DEVIATION 1.25 • n=5 Participants	3.92 years STANDARD_DEVIATION 1.83 • n=7 Participants	4.08 years STANDARD_DEVIATION 2.41 • n=5 Participants	3.58 years STANDARD_DEVIATION 1.83 • n=4 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	23 Participants n=7 Participants	17 Participants n=5 Participants	64 Participants n=4 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	18 Participants n=7 Participants	25 Participants n=5 Participants	61 Participants n=4 Participants

PRIMARY outcome

Timeframe: Change from baseline Clostridium butyricum Miyairi expression at 3 months.

The expression of Clostridium butyricum Miyairi (CBM) in constipated children feces means a better outcome measure.

Outcome measures

Outcome measures
Measure	Magnesium Oxide and MIYAIRI-BM n=42 Participants 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. Magnesium Oxide: 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 MIYAIRI-BM: 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	Magnesium Oxide n=41 Participants 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. Magnesium Oxide: 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	Healthy Children n=42 Participants Healthy children without any treatment
Change of Clostridium Butyricum Miyairi Expression After Probiotics Supplementation in Constipated Children.	0.00486 number of bacteria per mg of feces Standard Deviation 0.00696	0.0000148 number of bacteria per mg of feces Standard Deviation 0.0000266	0.00000189 number of bacteria per mg of feces Standard Deviation 0.00000341

Adverse Events

Magnesium Oxide and MIYAIRI-BM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Magnesium Oxide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hsun-Chin Chao

Chang Gung Memorial Hospital

Phone: 88633281200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place