Constipation
Conditions
Brief summary
The main objective of this Pilot study was to assess the beneficial effects of a daily supplementation with Orafti inulin-type fructans in 2-5 year old constipated children The study is primary aimed to develop a feasibility study to assess the beneficial effect of inulin-type fructans in the described population with regard to the adequate criteria for a larger trial. Secondary objectives are to obtain data about the feasibility of the protocol (as pilot study). To obtain data useful to perform sample size calculations for a big study designed specifically to investigate the beneficial effect of inulin-type fructans in the treatment of constipated children. Study design and subjects: Double-blind, randomized, placebo-controlled parallel group trial; where 2-5 year-old constipated children received inulin-type fructans or the same amount of placebo (maltodextrin) during 6 weeks. The study protocol was approved by the local Ethical Committees. Outcomes: primary outcome was stool consistency. Secondary outcomes were: stool frequency, gastrointestinal symptoms (abdominal pain and pain during defecation), additional medication required (yes/no), and colonic transit time. Stool samples at baseline, end of intervention and after follow-up were obtained in order to be analysed to know about the microbiota. Dietary intake was also recorded at baseline, end of intervention and after follow-up. Principal subject inclusion criteria: Subjects were recruited if fulfil the Rome III constipation criteria (Mainly hard stools plus stool retention, or pain, or low frequency). Principal subject exclusion criteria: Age under 2 or over 5 years, diapers use, use of laxative during the study and 2 weeks before, use of pre- probiotics or antibiotics during the study and 4 weeks before, organic causes of defecation disorders, other metabolic or renal abnormalities or mental retardation, no parent's command of any local language.
Detailed description
Double-blind, randomised, placebo-controlled parallel group trial (Pilot) Constipated children received two doses of 2g Orafti® inulin-type fructans (OF:IN) or placebo (maltodextrin) for 6 weeks. Primary outcome was stool consistency. Secondary outcomes were stool frequency and gastrointestinal symptoms. Sample size recruited: twenty-two children, from whom 17 completed the study protocol (nine for the OF:IN and eight for the control group).
Interventions
DIETARY_SUPPLEMENTOraftiR inulin-type fructans
DIETARY_SUPPLEMENTPlacebo
maltodextrin
Sponsors
Beneo GmbH
Institut Investigacio Sanitaria Pere Virgili
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* Two to 5 year-old constipated children with sufficient toilet training. * To acomplish the Romee I criteria for infants up to 4 yeras. Briefly: have to fulfil at least 2 of the following criteria for at least 1 month: 1. Two or fewer defecations per week 2. At least 1 episode per week of incontinence after the acquisition of toileting skills 3. History of excessive stool retention 4. History of painful or hard bowel movements 5. Presence of a large faecal mass in the rectum 6. History of large-diameter stools that may obstruct the toilet Accompanying symptoms may include irritability, decreased appetite and/or early satiety. Accompanying symptoms disappear immediately following passage of a large stool.
Exclusion criteria
* No child's control of defecation (use of diapers). * No mother's command of any local language. * Organic causes of defecation disorders incl. Hirschsprung's disease, Spina bifida, hypothyroidism, celiac disease etc. * Other metabolic or renal abnormalities or mental retardation (Child's mental delay). * Use of drugs (e.g. antibiotics) and labelled pre- and probiotics influencing gastrointestinal function (4 weeks before run-in, 6 weeks before intervention). * Use of laxatives in the previous 2 weeks before the beginning of run-in (4 weeks before intervention).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool Consistency | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool Frequency | 6 weeks of treatment | Assessed by a continuous daily bowel diary and expressed as average of stools per week |
| Abdominal Pain | 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) |
| Pain During Defecation | 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) |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Maltodextrin 2g, twice per day, 6 weeks
Placebo: maltodextrin | 11 |
| Inulin-Type Fructans Orafti inulin-type fructans 2g, twice per day, 6 weeks
OraftiR inulin-type fructans | 11 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 2 |
Baseline characteristics
| Characteristic | Inulin-Type Fructans | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 3.72 years STANDARD_DEVIATION 1.07 | 4.03 years STANDARD_DEVIATION 0.79 | 3.75 years STANDARD_DEVIATION 0.91 |
| Region of Enrollment Spain | 11 participants | 11 participants | 22 participants |
| Sex: Female, Male Female | 3 Participants | 9 Participants | 12 Participants |
| Sex: Female, Male Male | 8 Participants | 2 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Stool Consistency
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.
Time frame: 6 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Stool Consistency | 2.57 units on a scale | Standard Deviation 0.58 |
| Inulin-Type Fructans | Stool Consistency | 1.63 units on a scale | Standard Deviation 0.64 |
Secondary
Abdominal Pain
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)
Time frame: 6 weeks of treatment
Secondary
Pain During Defecation
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)
Time frame: 6 weeks of treatment
Secondary
Stool Frequency
Assessed by a continuous daily bowel diary and expressed as average of stools per week
Time frame: 6 weeks of treatment