Trial Outcomes & Findings for Effect of Inulin-type Fructans on Constipated Children. (NCT NCT02863848)

Results Overview

Stool consistency was measured according to the Modified Bristol Stool Form Scale for children (from 1 to 5, having lower scores a more hard stool characteristics). Assessed by a continuous daily bowel diary over the following period and in accordance with the Modified Bristol Stool Form Scale for Children. The average consistency from all depositions reported in each follow-up period was obtained for each participant.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

6 weeks of treatment

Results posted on

2024-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Maltodextrin 2g, twice per day, 6 weeks Placebo: maltodextrin	Inulin-Type Fructans Orafti inulin-type fructans 2g, twice per day, 6 weeks OraftiR inulin-type fructans
Overall Study STARTED	11	11
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Maltodextrin 2g, twice per day, 6 weeks Placebo: maltodextrin	Inulin-Type Fructans Orafti inulin-type fructans 2g, twice per day, 6 weeks OraftiR inulin-type fructans
Overall Study Lost to Follow-up	1	1
Overall Study Protocol Violation	1	2

Baseline Characteristics

Effect of Inulin-type Fructans on Constipated Children.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=11 Participants Maltodextrin 2g, twice per day, 6 weeks Placebo: maltodextrin	Inulin-Type Fructans n=11 Participants Orafti inulin-type fructans 2g, twice per day, 6 weeks OraftiR inulin-type fructans	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	11 Participants n=93 Participants	11 Participants n=4 Participants	22 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	4.03 years STANDARD_DEVIATION 0.79 • n=93 Participants	3.72 years STANDARD_DEVIATION 1.07 • n=4 Participants	3.75 years STANDARD_DEVIATION 0.91 • n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	3 Participants n=4 Participants	12 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	8 Participants n=4 Participants	10 Participants n=27 Participants
Region of Enrollment Spain	11 participants n=93 Participants	11 participants n=4 Participants	22 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 weeks of treatment

Stool consistency was measured according to the Modified Bristol Stool Form Scale for children (from 1 to 5, having lower scores a more hard stool characteristics). Assessed by a continuous daily bowel diary over the following period and in accordance with the Modified Bristol Stool Form Scale for Children. The average consistency from all depositions reported in each follow-up period was obtained for each participant.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Placebo: Maltodextrin 2g, twice per day, 6 weeks	Inulin-Type Fructans n=8 Participants Orafti inulin-type fructans 2g, twice per day, 6 weeks
Stool Consistency	2.57 units on a scale Standard Deviation 0.58	1.63 units on a scale Standard Deviation 0.64

SECONDARY outcome

Timeframe: 6 weeks of treatment

Assessed by a continuous daily bowel diary and expressed as average of stools per week

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks of treatment

Assessed by daily bowel diary and Wong-Baker Faces Pain Rating Scale (scale from 0 to 10 being 0 "no pain" and 10 the "maximum level of pain")

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks of treatment

Assessed by daily bowel diary and Wong-Baker Faces Pain Rating Scale (scale from 0 to 10 being 0 "no pain" and 10 the "maximum level of pain")

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inulin-Type Fructans

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. Joaquin Escribano

Universitat Rovira i virgili

Phone: + 34 977 759364

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place