NCT02016703

Brief Summary

Purpose of this study: assess the maximum tolerated bolus dose of erythritol, delivered in a clear beverage, compared with placebo (saccharose) in 4-6 year old children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
Last Updated

July 19, 2017

Status Verified

December 1, 2013

Enrollment Period

3.3 years

First QC Date

December 16, 2013

Last Update Submit

July 18, 2017

Conditions

GastrointestinalTolerance

Keywords

erythritolpolyollaxationgastrointestinaltolerancesoft drinkschilddiarrhoea

Outcome Measures

Primary Outcomes (1)

  • Diarrhoea and/or significant gastrointestinal (GI) symptoms

    Diarrhoea = a single watery stool (Bristol Stool Scale Score of 7) and/or \>3 faeces (regardless of consistency) in a 24 h period. Significant GI symptoms = any GI symptoms having a severity recorded as "severe intensity" in the symptom diary

    48 hours

Secondary Outcomes (4)

  • Stool frequency

    48 hours

  • Stool consistency

    48 hours

  • Gastrointestinal symptoms

    24 hours

  • Urinary erythritol excretion

    24 hours

Study Arms (4)

5 g group

EXPERIMENTAL

5g erythritol dissolved in 250 ml (2% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions)

Other: Erythritol drinkOther: Placebo drink

15 g group

EXPERIMENTAL

15g erythritol dissolved in 250 ml (6% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions)

Other: Erythritol drinkOther: Placebo drink

25 g group

EXPERIMENTAL

25g erythritol dissolved in 250 ml (10% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions)

Other: Erythritol drinkOther: Placebo drink

20 g group

EXPERIMENTAL

20g erythritol dissolved in 250 ml (8% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions)

Other: Erythritol drinkOther: Placebo drink

Interventions

Erythritol drinkOTHER
15 g group20 g group25 g group5 g group
Placebo drinkOTHER
15 g group20 g group25 g group5 g group

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy
  • Age 4 to 6 years at Study D1 (day of consumption of the first beverage)
  • Body Mass Index ³ 13 kg/m²
  • Accustomed to having breakfast
  • Having a regular defecation frequency inferior or equal to two per day
  • Able to drink 250 mL within 15 minutes
  • Toilet-trained / able to use a potty (both at day and night)
  • Informed consent of both person entitled to parental rights
  • Person entitled to parental rights affiliated to the French social security

You may not qualify if:

  • Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before D1 of the study
  • Participation in any non-invasive clinical trial up to 30 days before D1 of this study, including blood sampling and/ or, intravenous, inhalatory administration of substances
  • Having a history of medical or surgical events that may significantly affect the study outcome, such as gastric and digestive diseases
  • Any current metabolic or endocrine disease, including diabetes mellitus
  • Use of medication, including antibiotics, laxatives and steroids
  • Regular gastrointestinal complaints, such as stomach upsets, diarrhoea, constipation, flatulence, abdominal colic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinical Investigation Centre Louis Pradel Hospital

Bron, 69677, France

Location

Biofortis Merieux NutriSciences

Nantes, 44800, France

Location

Clinical Investigation Centre Robert Debré Hospital

Paris, 75935, France

Location

Related Publications (8)

  • Bornet FR, Blayo A, Dauchy F, Slama G. Plasma and urine kinetics of erythritol after oral ingestion by healthy humans. Regul Toxicol Pharmacol. 1996 Oct;24(2 Pt 2):S280-5. doi: 10.1006/rtph.1996.0109.

    PMID: 8933644BACKGROUND

  • Arrigoni E, Brouns F, Amado R. Human gut microbiota does not ferment erythritol. Br J Nutr. 2005 Nov;94(5):643-6. doi: 10.1079/bjn20051546.

    PMID: 16277764BACKGROUND

  • Bornet FR, Blayo A, Dauchy F, Slama G. Gastrointestinal response and plasma and urine determinations in human subjects given erythritol. Regul Toxicol Pharmacol. 1996 Oct;24(2 Pt 2):S296-302. doi: 10.1006/rtph.1996.0111.

    PMID: 8933646BACKGROUND

  • Tetzloff W, Dauchy F, Medimagh S, Carr D, Bar A. Tolerance to subchronic, high-dose ingestion of erythritol in human volunteers. Regul Toxicol Pharmacol. 1996 Oct;24(2 Pt 2):S286-95. doi: 10.1006/rtph.1996.0110.

    PMID: 8933645BACKGROUND

  • Munro IC, Berndt WO, Borzelleca JF, Flamm G, Lynch BS, Kennepohl E, Bar EA, Modderman J. Erythritol: an interpretive summary of biochemical, metabolic, toxicological and clinical data. Food Chem Toxicol. 1998 Dec;36(12):1139-74. doi: 10.1016/s0278-6915(98)00091-x.

    PMID: 9862657BACKGROUND

  • Storey D, Lee A, Bornet F, Brouns F. Gastrointestinal tolerance of erythritol and xylitol ingested in a liquid. Eur J Clin Nutr. 2007 Mar;61(3):349-54. doi: 10.1038/sj.ejcn.1602532. Epub 2006 Sep 20.

    PMID: 16988647BACKGROUND

  • Lifshitz F, Ament ME, Kleinman RE, Klish W, Lebenthal E, Perman J, Udall JN Jr. Role of juice carbohydrate malabsorption in chronic nonspecific diarrhea in children. J Pediatr. 1992 May;120(5):825-9. doi: 10.1016/s0022-3476(05)80260-4. No abstract available.

    PMID: 1578324BACKGROUND

  • Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.

    PMID: 9299672BACKGROUND

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Evelyne Jacqz-Aigrain, PhD

    Clinical Investigation Centre Robert Debré Hospital, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2013

First Posted

December 20, 2013

Study Start

March 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2010

Last Updated

July 19, 2017

Record last verified: 2013-12

Locations

FR(3)