Trial Outcomes & Findings for Lcr35 for Children With Functional Constipation (NCT NCT01985867)

NCT ID: NCT01985867

Last Updated: 2023-05-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 94 participants
• Primary outcome timeframe: in the fourth week of the intervention
• Results posted on: 2023-05-17

Participant Flow

Participant milestones

Measure	Lactobacillus Casei Rhamnosus Lcr35 Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Overall Study STARTED	48	46
Overall Study COMPLETED	41	40
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Measure	Lactobacillus Casei Rhamnosus Lcr35 Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Overall Study Lost to Follow-up	3	4
Overall Study Adverse Event	3	2
Overall Study Lack of Efficacy	1	0

Baseline Characteristics

Lcr35 for Children With Functional Constipation

Baseline characteristics by cohort

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=48 Participants Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=46 Participants Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks	Total n=94 Participants Total of all reporting groups
Age, Continuous	38.7 month STANDARD_DEVIATION 12.1 • n=5 Participants	37.3 month STANDARD_DEVIATION 14.2 • n=7 Participants	38 month STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment Poland	48 Participants n=5 Participants	46 Participants n=7 Participants	94 Participants n=5 Participants
Age of onset of constipation	24.0 months STANDARD_DEVIATION 12.1 • n=5 Participants	23.5 months STANDARD_DEVIATION 12.9 • n=7 Participants	23.77 months STANDARD_DEVIATION 12.45 • n=5 Participants
Duration of constipation	14.7 months STANDARD_DEVIATION 9.1 • n=5 Participants	13.8 months STANDARD_DEVIATION 11.1 • n=7 Participants	14.3 months STANDARD_DEVIATION 10.1 • n=5 Participants
Stools per week	1.6 Stools per week STANDARD_DEVIATION 0.5 • n=5 Participants	1.6 Stools per week STANDARD_DEVIATION 0.5 • n=7 Participants	1.6 Stools per week STANDARD_DEVIATION 0.5 • n=5 Participants
Stool consistency, Bristol scale	1.5 units on a scale STANDARD_DEVIATION 1.0 • n=5 Participants	1.7 units on a scale STANDARD_DEVIATION 0.9 • n=7 Participants	1.6 units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants
Fecal soiling	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Pain during defecation	47 Participants n=5 Participants	44 Participants n=7 Participants	91 Participants n=5 Participants
Withholding behavior	44 Participants n=5 Participants	41 Participants n=7 Participants	85 Participants n=5 Participants
Abdominal pain	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Blood in the stool	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Previous treatment for intestinal constipation	40 Participants n=5 Participants	37 Participants n=7 Participants	77 Participants n=5 Participants
Rectal impaction	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants

PRIMARY outcome

Timeframe: in the fourth week of the intervention

Outcome measures

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=48 Participants Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=46 Participants Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling	24 Participants	28 Participants

SECONDARY outcome

Timeframe: during fourth week of intervention

Stool consistency scores were determined using the 7-point Bristol Stool Form Scale (1 for hard lumps to 7 for watery stools).

For single value median was calculated.

Outcome measures

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=41 Participants Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=40 Participants Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Stool Consistency at Week 4	3.5 units on a scale Interval 2.8 to 4.0	3.7 units on a scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: during fourth week of intervention

For single value median was calculated.

Outcome measures

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=41 Participants Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=40 Participants Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Defecation Frequency at Week 4	4.0 defecations per week Interval 3.0 to 5.0	6.0 defecations per week Interval 4.0 to 9.0

SECONDARY outcome

Timeframe: during fourth week of intervention

For single value median was calculated.

Outcome measures

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=41 Participants Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=40 Participants Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Fecal Soiling Episodes at Week 4	0.0 fecal soiling episodes Interval 0.0 to 0.0	0.0 fecal soiling episodes Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: during fourth weeks of intervention

Pain reported by child or symptoms of pain observed by parents. For single value median was calculated.

Outcome measures

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=41 Participants Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=40 Participants Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Number of Defecations That Were Painful at Week 4	0.0 painful defecations Interval 0.0 to 1.0	0.0 painful defecations Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: during fourth weeks of intervention

Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.

Outcome measures

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=41 Participants Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=40 Participants Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Abdominal Pain at Week 4	0.0 abdominal pain episodes Interval 0.0 to 0.0	0.0 abdominal pain episodes Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: during 4 weeks of intervention

Outcome measures

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=41 Participants Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=40 Participants Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Number of Participants With Use of Laxatives	18 Participants	10 Participants

SECONDARY outcome

Timeframe: during 4 weeks of intervention

Outcome measures

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=41 Participants Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=40 Participants Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Number of Participants With Adverse Effects	0 Participants	3 Participants

SECONDARY outcome

Timeframe: during first week of intervention

Stool consistency scores were determined using the 7-point Bristol Stool Form Scale (1 for hard lumps to 7 for watery stools).

For single value median was calculated.

Outcome measures

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=41 Participants Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=40 Participants Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Stool Consistency at Week 1	3.6 units on a scale Interval 3.0 to 4.0	3.9 units on a scale Interval 2.8 to 4.3

SECONDARY outcome

Timeframe: during first week of intervention

Outcome measures

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=41 Participants Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=40 Participants Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Defecation Frequency at Week 1	5.0 defecations per week Interval 3.0 to 6.0	6.0 defecations per week Interval 5.0 to 8.2

SECONDARY outcome

Timeframe: during first week of intervention

Outcome measures

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=41 Participants Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=40 Participants Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Fecal Soiling Episodes at Week 1	0.0 fecal soiling episodes Interval 0.0 to 0.0	0.0 fecal soiling episodes Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: during first weeks of intervention

Pain reported by child or symptoms of pain observed by parents. For single value median was calculated.

Outcome measures

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=41 Participants Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=40 Participants Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Pain During Defecation at Week 1	0.0 painful defecations Interval 0.0 to 1.0	0.0 painful defecations Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: during first weeks of intervention

Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.

Outcome measures

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=41 Participants Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=4 Participants Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Abdominal Pain at Week 1	0.0 abdominal pain episodes Interval 0.0 to 0.0	0.0 abdominal pain episodes Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: during fourth weeks of intervention

Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.

Outcome measures

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=41 Participants Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=40 Participants Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Flatulence at Week 4	0.0 episodes of flatulence Interval 0.0 to 0.0	0.0 episodes of flatulence Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: during first weeks of intervention

Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.

Outcome measures

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=41 Participants Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=40 Participants Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Flatulence at Week 1	0.0 episodes of flatulence Interval 0.0 to 1.0	0.0 episodes of flatulence Interval 0.0 to 0.2

Adverse Events

Lactobacillus Casei Rhamnosus Lcr35

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lactobacillus Casei Rhamnosus Lcr35 n=48 participants at risk Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks Lactobacillus casei rhamnosus Lcr35: Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)	Placebo n=46 participants at risk Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks Placebo: Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Gastrointestinal disorders change in the stool smell	0.00% 0/48 • during 4 weeks of the intervention	2.2% 1/46 • Number of events 1 • during 4 weeks of the intervention
Gastrointestinal disorders abdominal pain and flatulence	0.00% 0/48 • during 4 weeks of the intervention	2.2% 1/46 • Number of events 1 • during 4 weeks of the intervention
Gastrointestinal disorders loss of appetite	0.00% 0/48 • during 4 weeks of the intervention	2.2% 1/46 • Number of events 1 • during 4 weeks of the intervention

Additional Information

Katarzyna Wojtyniak

The Medical University of Warsaw

Phone: +48 22 317 94 21

Email: wojtyniakkasia@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place