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Effect of Inulin-type Fructans on Constipated Children. (CONSTICHILD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02863848
Recruitment Status : Completed
First Posted : August 11, 2016
Last Update Posted : August 11, 2016
Sponsor:
Collaborator:
Beneo GmbH
Information provided by (Responsible Party):
Dr. Joaquin Escribano, Institut Investigacio Sanitaria Pere Virgili

Study Description
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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.


Condition or disease Intervention/treatment Phase
Constipation Dietary Supplement: OraftiR inulin-type fructans Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Inulin-type Fructans on Constipated Children. Pilot Study.
Study Start Date : September 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Inulin

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Maltodextrin 2g, twice per day, 6 weeks
 Dietary Supplement: Placebo
maltodextrin
Active Comparator: Inulin-type fructans
Orafti inulin-type fructans 2g, twice per day, 6 weeks
 Dietary Supplement: OraftiR inulin-type fructans


Outcome Measures
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Primary Outcome Measures :
  1. Stool consistency (Assessed by a continuous daily bowel diary over the following period and in accordance with the Modified Bristol Stool Form Scale for Children) [ Time Frame: 6 weeks of treatment ]

Secondary Outcome Measures :
  1. Stool frequency (Assessed by a continuous daily bowel diary and expressed as stools per week) [ Time Frame: 6 weeks of treatment ]
  2. Abdominal pain (Assessed by daily bowel diary and Wong-Baker FACES Pain Rating Scale) [ Time Frame: 6 weeks of treatment ]
  3. Pain during defecation (Assessed by daily bowel diary and Wong-Baker FACES Pain Rating Scale) [ Time Frame: 6 weeks of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863848


Locations
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Spain
Iispv- Hospital Sant Joan de Reus
Reus, Tarragona, Spain, E43204
Sponsors and Collaborators
Institut Investigacio Sanitaria Pere Virgili
Beneo GmbH
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Joaquin Escribano, Head of the Paediatrics, Nutrition and Human Development Research Unit Universitat Rovira i Virgili - IISPV, Institut Investigacio Sanitaria Pere Virgili
ClinicalTrials.gov Identifier: NCT02863848    
Other Study ID Numbers: CONSTICHILD
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results about the pilot study will be published.
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive