Trial Outcomes & Findings for The Role of Lactobacillus Reuteri in Children and Adolescents With Anorexia Nervosa (NCT NCT02004288)

NCT ID: NCT02004288

Last Updated: 2021-06-23

Results Overview

Drop out from Rome III criteria for constipation: Yes / No. According to Rome III, a diagnosis of functional constipation is made when at least two of the following criteria are met for the last 3 months with symptom onset at least 6 months prior to diagnosis: a) straining on \>25% of defecations; b) lumpy or hard stools on \>25% of defecations; c) sensation of incomplete evacuation on \>25% of defecations; d) sensation of anorectal obstruction/blockage on \>25% of defecations; e) manual maneuvers on \>25% of defecations; and f) less than 3 defecations per week.

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

3 month

Results posted on

2021-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	Lactobacillus Reuteri Protectis DSM17938 One chewable tablet twice per day with L reuteri Protectis DSM 17938, 1x108 CFU/tablet (colony forming unit) Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months.	Placebo One chewable tablet twice per day with placebo per day Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months.
Overall Study STARTED	15	16
Overall Study COMPLETED	14	15
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lactobacillus Reuteri Protectis DSM17938 n=15 Participants One chewable tablet twice per day with L reuteri Protectis DSM 17938, 1x108 CFU/tablet (colony forming unit) Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months.	Placebo n=16 Participants One chewable tablet twice per day with placebo per day Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months.	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=15 Participants	16 Participants n=16 Participants	31 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=15 Participants	0 Participants n=16 Participants	0 Participants n=31 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants	0 Participants n=16 Participants	0 Participants n=31 Participants
Age, Continuous	15.06 years STANDARD_DEVIATION 2.31 • n=15 Participants	15.13 years STANDARD_DEVIATION 1.70 • n=16 Participants	15.06 years STANDARD_DEVIATION 1.96 • n=31 Participants
Sex: Female, Male Female	15 Participants n=15 Participants	16 Participants n=16 Participants	31 Participants n=31 Participants
Sex: Female, Male Male	0 Participants n=15 Participants	0 Participants n=16 Participants	0 Participants n=31 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Croatia	15 participants n=15 Participants	16 participants n=16 Participants	31 participants n=31 Participants

PRIMARY outcome

Timeframe: 3 month

Outcome measures

Outcome measures
Measure	Lactobacillus Reuteri Protectis DSM17938 n=15 Participants One chewable tablet twice per day with L reuteri Protectis DSM 17938, 1x108 CFU/tablet (colony forming unit) Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months.	Placebo n=16 Participants One chewable tablet twice per day with placebo per day Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months.
Number of Participants That Drop Out From Rome III Criteria for Constipation	13 Participants	10 Participants

SECONDARY outcome

Timeframe: 6 month

normalization of body weight- 90% of premorbid weight, or ≥10. centile for BMI (according to the WHO growth charts)

Outcome measures

Outcome measures
Measure	Lactobacillus Reuteri Protectis DSM17938 n=15 Participants One chewable tablet twice per day with L reuteri Protectis DSM 17938, 1x108 CFU/tablet (colony forming unit) Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months.	Placebo n=16 Participants One chewable tablet twice per day with placebo per day Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months.
Normalization of Body Weight	14 Participants	10 Participants

Adverse Events

Lactobacillus Reuteri Protectis DSM17938

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Orjena Žaja, MD MSc PhD primarius Ass Prof Pediatrics, Pediatric gastroenterologist

Sestre milosrdnice University Hospital Center Vinogradska 29, Zagreb, Croatia

Phone: P:+38513787342 M:+3859937872

Email: Orjena Žaja <[email protected]>

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place