Tolerability and Acceptability of Fibersol-2 in Children

NCT03565393 | Completed Phase 1 DMC

• 1 other identifier: PR-16091
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea

Keywords

Tolerability; Acceptability; Fibersol-2; Children

Outcome Measures

Primary Outcomes (2)

• Duration of diarrhea

  Main outcome measure is duration of diarrhea

  72 hours

• Stool consistency.

  Stool consistency measured by regular observation

  24 hrs

Study Arms (2)

Fibersol-2

PLACEBO COMPARATOR

Receive Fibersol-2 twice daily

Combination Product: Fibersol-2

Placebo

PLACEBO COMPARATOR

Receive placebo twice daily

Combination Product: Fibersol-2

Interventions

Fibersol-2 COMBINATION_PRODUCT

A placebo-controlled, randomized; double-blind 2 arm trial

Fibersol-2; Placebo

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Kumudini Medical College and hospital, Mirzapur, Tangail

Dhaka, 1212, Bangladesh

Location

Related Publications (13)

• Hillemeier C. An overview of the effects of dietary fiber on gastrointestinal transit. Pediatrics. 1995 Nov;96(5 Pt 2):997-9.

  PMID: 7494680 RESULT

• Kishimoto Y, Kanahori S, Sakano K, Ebihara S. The maximum single dose of resistant maltodextrin that does not cause diarrhea in humans. J Nutr Sci Vitaminol (Tokyo). 2013;59(4):352-7. doi: 10.3177/jnsv.59.352.

  PMID: 24064737 RESULT

• Livesey G. Tolerance of low-digestible carbohydrates: a general view. Br J Nutr. 2001 Mar;85 Suppl 1:S7-16. doi: 10.1079/bjn2000257.

  PMID: 11321031 RESULT

• Bonnema AL, Kolberg LW, Thomas W, Slavin JL. Gastrointestinal tolerance of chicory inulin products. J Am Diet Assoc. 2010 Jun;110(6):865-8. doi: 10.1016/j.jada.2010.03.025.

  PMID: 20497775 RESULT

• Castillejo G, Bullo M, Anguera A, Escribano J, Salas-Salvado J. A controlled, randomized, double-blind trial to evaluate the effect of a supplement of cocoa husk that is rich in dietary fiber on colonic transit in constipated pediatric patients. Pediatrics. 2006 Sep;118(3):e641-8. doi: 10.1542/peds.2006-0090.

  PMID: 16950955 RESULT

• King DE, Mainous AG 3rd, Lambourne CA. Trends in dietary fiber intake in the United States, 1999-2008. J Acad Nutr Diet. 2012 May;112(5):642-8. doi: 10.1016/j.jand.2012.01.019. Epub 2012 Apr 25.

  PMID: 22709768 RESULT

• McGill CR, Fulgoni VL 3rd, Devareddy L. Ten-year trends in fiber and whole grain intakes and food sources for the United States population: National Health and Nutrition Examination Survey 2001-2010. Nutrients. 2015 Feb 9;7(2):1119-30. doi: 10.3390/nu7021119.

  PMID: 25671414 RESULT

• Fastinger ND, Karr-Lilienthal LK, Spears JK, Swanson KS, Zinn KE, Nava GM, Ohkuma K, Kanahori S, Gordon DT, Fahey GC Jr. A novel resistant maltodextrin alters gastrointestinal tolerance factors, fecal characteristics, and fecal microbiota in healthy adult humans. J Am Coll Nutr. 2008 Apr;27(2):356-66. doi: 10.1080/07315724.2008.10719712.

  PMID: 18689571 RESULT

• Ye Z, Arumugam V, Haugabrooks E, Williamson P, Hendrich S. Soluble dietary fiber (Fibersol-2) decreased hunger and increased satiety hormones in humans when ingested with a meal. Nutr Res. 2015 May;35(5):393-400. doi: 10.1016/j.nutres.2015.03.004. Epub 2015 Mar 18.

  PMID: 25823991 RESULT

• Guimaraes EV, Goulart EM, Penna FJ. Dietary fiber intake, stool frequency and colonic transit time in chronic functional constipation in children. Braz J Med Biol Res. 2001 Sep;34(9):1147-53. doi: 10.1590/s0100-879x2001000900007.

  PMID: 11514838 RESULT

• Gibson GR, Roberfroid MB. Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr. 1995 Jun;125(6):1401-12. doi: 10.1093/jn/125.6.1401.

  PMID: 7782892 RESULT

• Shahid ASMSB, Ahmed S, Dash S, Kishimoto Y, Kanahori S, Ahmed T, Faruque ASG, Chisti MJ. Is Fibersol-2 efficacious in reducing duration of watery diarrhea and stool output in children 1-3 years old? A randomized, parallel, double-blinded, placebo-controlled, two arm clinical trial. PLoS One. 2023 Jan 27;18(1):e0280934. doi: 10.1371/journal.pone.0280934. eCollection 2023.

  PMID: 36706123 DERIVED

• Shahid ASMSB, Ahmed S, Renesa TT, Onni AT, Dash S, Kishimoto Y, Kanahori S, Ahmed T, Faruque ASG, Chisti MJ. Digestive tolerability and acceptability of Fibersol-2 in healthy and diarrheal children 1-3 years old at a rural facility, Bangladesh: Results from a four arm exploratory study. PLoS One. 2022 Sep 19;17(9):e0274302. doi: 10.1371/journal.pone.0274302. eCollection 2022.

  PMID: 36121843 DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammod Jo Chisti, MMed PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A placebo-controlled, randomized; double-blind 2 arm trial to assess the efficacy of fibersol-2 in children with acute watery diarrhea.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A placebo-controlled, randomized

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: June 21, 2018
• Study Start: March 19, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: February 26, 2020

Record last verified: 2018-03

Locations

BA (1)