Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tolerability and Acceptability of Fibersol-2 in Children

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: NCT03565393
Recruitment Status : Completed
First Posted : June 21, 2018
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:
Dietary fiber, a non-digestible carbohydrate, used in decades for the beneficial effect on health with physiological importance because such compounds have low energy values. These indigestible carbohydrates generally reach the large intestine undigested and unabsorbed, they are often used in many functional and/or low-calorie food and beverages. Researchers have stated that dietary fiber especially digestive-resistant maltodextrin has innumerable beneficial effects on human health, such as improving intestinal regularity by increasing fecal bulk, stimulating peristalsis and shortening gastrointestinal transit time. Resistant maltodextrin (Fibersol-2) is a low viscosity, water-soluble, indigestible dextrin produced by the treatment of corn starch with acid, enzymes, and heat. Dietary fiber, a non-digestible carbohydrate, has been used in decades for the beneficial effect of health with physiological importance. In developing countries most of the diarrhea episodes occur during the first two years of life and till date antibiotics have been found to have no role in over seventy five percent of young childhood diarrhea. Toddler's diarrhea which affects children aged 6 to 60 months is known as chronic nonspecific diarrhea of childhood. The stool is frequently watery or loose and may have food particles in it. Despite the diarrhea, the child continues to grow and gain weight, remains active and has a normal appetite. The beneficial effects of resistant maltodextrin are well known in developed countries; however, data are lacking in developing countries. It has become imperative to know its safety, tolerability and acceptability in small children with or without diarrhea in developing countries such as in Bangladesh.

Condition or disease Intervention/treatment Phase
Diarrhea Combination Product: Fibersol-2 Phase 1 Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A placebo-controlled, randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: A placebo-controlled, randomized; double-blind 2 arm trial to assess the efficacy of fibersol-2 in children with acute watery diarrhea.
Primary Purpose: Supportive Care
Official Title: Tolerability and Acceptability of Fibersol-2 (Resistant Maltodextrin) in Healthy and Diarrheal Children Followed by a Randomized Clinical Trial to Evaluate the Efficacy of Fibersol-2 in Diarrheal Children 1-3 Years Old
Actual Study Start Date : March 19, 2018
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Placebo Comparator: Fibersol-2
Receive Fibersol-2 twice daily
Combination Product: Fibersol-2
A placebo-controlled, randomized; double-blind 2 arm trial

Placebo Comparator: Placebo
Receive placebo twice daily
Combination Product: Fibersol-2
A placebo-controlled, randomized; double-blind 2 arm trial




Primary Outcome Measures :
  1. Duration of diarrhea [ Time Frame: 72 hours ]
    Main outcome measure is duration of diarrhea

  2. Stool consistency. [ Time Frame: 24 hrs ]
    Stool consistency measured by regular observation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with acute watery diarrhea, 3 or more watery stool in any 24-hour period of <7 days duration with none or some dehydration
  • Aged between 1-3 years, and
  • Received written consent from parents

Exclusion Criteria:

  • Children with bloody diarrhea, severe diseases (severe sepsis, meningitis, severe pneumonia with respiratory distress requiring intensive care and ancillary support such as oxygen inhalation, orophryngeal suction etc.
  • Child in a situation and could interfere with the optimal participation to the study or constitute a particular risk of non-compliance
  • Currently participating in another clinical trial, and
  • Parents refused to give written consent.

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): NCT03565393


Locations
Layout table for location information
Bangladesh
Kumudini Medical College and hospital, Mirzapur, Tangail
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Layout table for investigator information
Principal Investigator: Mohammod Jo Chisti, MMed PhD International Centre for Diarrhoeal Disease Research, Bangladesh
Publications of Results:

Layout table for additonal information
Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03565393    
Other Study ID Numbers: PR-16091
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Tolerability
Acceptability
Fibersol-2
Children
Additional relevant MeSH terms:
Layout table for MeSH terms
Diarrhea
Signs and Symptoms, Digestive