GastrointestinalNCT02016703
Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children
A study testing Erythritol drink in people with Gastrointestinal and Tolerance, run by Cargill at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal, Tolerance
- What is being tested?
- Erythritol drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2006to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Clinical Investigation Centre Louis Pradel Hospital
Bron, 69677
Biofortis Merieux NutriSciences
Nantes, 44800
Clinical Investigation Centre Robert Debré Hospital
Paris, 75935
About this study
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.
Read the detailed description
The study is a randomized placebo-controlled, double-blind cross-over trial designed to determine the gastrointestinal (GI) responses and maximum tolerated dose of erythritol in young children as a single oral dose in a beverage in-between meals.
The children were divided into 4 dose groups. In each group of children, only one dose level was tested such that each child was exposed to only a single dose level versus placebo. The erythritol dose started at 5 grams and was increased by 10 g between each group of children only if the preceding dose level was found to have no significant GI tolerance effects. The effects on faecal parameters and gastrointestinal complaints were recorded in order to determine the threshold dose. After finding a significant difference in tolerance between erythritol and placebo in the 25 g dose cohort, a protocol amendment was approved allowing the investigators to study a dose of 20 g.
Test materials were prepared by Cargill, Vilvoorde, Belgium and supplied in bottles containing 250 mL of a noncarbonated fruit-flavoured (two flavours: strawberry and orange) clear drink sweetened with erythritol at four different dose levels: 5, 15, 20 and 25 g (equivalent to 2, 6, 8 and 10% w/v erythritol, respectively). Placebo was supplied in an identical manner but prepared with common nutritive carbohydrates (saccharose and maltodextrin) and providing an equivalent sweetness to that of the corresponding erythritol beverages (i.e.: 1.4, 4.2, 5.6 and 7% w/v).
In total 185 healthy young children aged 4-6 years were recruited at three clinical investigation centres after informed consent of both parents; 184 completed the study.
- Conditions
- Gastrointestinal, Tolerance
- Being tested
- Erythritol drink, Placebo drink
- Keywords
- erythritol, polyol, laxation, gastrointestinal, tolerance, soft drinks, child, diarrhoea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythritol drinkOther
Placebo drinkOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Erythritol drink; Other: 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) Receives: Other: Erythritol drink; Other: 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) Receives: Other: Erythritol drink; Other: 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) Receives: Other: Erythritol drink; Other: Placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Secondary outcomes (4)
Stool frequency
Measured: 48 hours
Stool consistency
Stools were assigned a consistency score using the Bristol Stool Scale
Measured: 48 hours
Gastrointestinal symptoms
Occurrence, intensity and frequency of borborygmi, excess flatus, abdominal pain, distended stomach (bloating) and nausea. For vomiting, information collected included occurrence and frequency. Symptom intensity was graded as 0 (none), 1 (mild), 2 (average) and 3 (severe) except for vomiting.
Measured: 24 hours
Urinary erythritol excretion
Urine was collected for 24 h after consumption of the test drink and analyzed by HPLC to estimate the proportion absorbed and excreted.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startMar 2006
- Primary completionJul 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for GastrointestinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cargill
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences
- Responsible party
- Sponsor
- Investigators
- Evelyne Jacqz-Aigrain, PhD, Principal investigator, Clinical Investigation Centre Robert Debré Hospital, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016703
- Sponsor's protocol ID
- CER-TDEOH05
- Status last verified
- Dec 2013
- First submitted
- 16 Dec 2013
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 8933644Arrigoni 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.
PubMed 16277764Bornet 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.
PubMed 8933646Tetzloff 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.
PubMed 8933645Munro 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.
PubMed 9862657Storey 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.
PubMed 16988647Lifshitz 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.
PubMed 1578324Lewis 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.
PubMed 9299672
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children
- ClinicalTrials.gov ID
- NCT02016703
- Acronym / sponsor ID
- CER-TDEOH05
- Conditions
- Gastrointestinal, Tolerance
- Keywords
- erythritol, polyol, laxation, gastrointestinal, tolerance, soft drinks, child, diarrhoea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- CargillIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences
- Study start
- Mar 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a randomized placebo-controlled, double-blind cross-over trial designed to determine the gastrointestinal (GI) responses and maximum tolerated dose of erythritol in young children as a single oral dose in a beverage in-between meals.
The children were divided into 4 dose groups. In each group of children, only one dose level was tested such that each child was exposed to only a single dose level versus placebo. The erythritol dose started at 5 grams and was increased by 10 g between each group of children only if the preceding dose level was found to have no significant GI tolerance effects. The effects on faecal parameters and gastrointestinal complaints were recorded in order to determine the threshold dose. After finding a significant difference in tolerance between erythritol and placebo in the 25 g dose cohort, a protocol amendment was approved allowing the investigators to study a dose of 20 g.
Test materials were prepared by Cargill, Vilvoorde, Belgium and supplied in bottles containing 250 mL of a noncarbonated fruit-flavoured (two flavours: strawberry and orange) clear drink sweetened with erythritol at four different dose levels: 5, 15, 20 and 25 g (equivalent to 2, 6, 8 and 10% w/v erythritol, respectively). Placebo was supplied in an identical manner but prepared with common nutritive carbohydrates (saccharose and maltodextrin) and providing an equivalent sweetness to that of the corresponding erythritol beverages (i.e.: 1.4, 4.2, 5.6 and 7% w/v).
In total 185 healthy young children aged 4-6 years were recruited at three clinical investigation centres after informed consent of both parents; 184 completed the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5 g group | Experimental | Other: Erythritol drink, Other: Placebo drink5g erythritol dissolved in 250 ml (2% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions) |
| 15 g group | Experimental | Other: Erythritol drink, Other: Placebo drink15g erythritol dissolved in 250 ml (6% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions) |
| 25 g group | Experimental | Other: Erythritol drink, Other: Placebo drink25g erythritol dissolved in 250 ml (10% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions) |
| 20 g group | Experimental | Other: Erythritol drink, Other: Placebo drink20g erythritol dissolved in 250 ml (8% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions) |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erythritol drink | Other | 15 g group, 20 g group, 25 g group, 5 g group |
| Placebo drink | Other | 15 g group, 20 g group, 25 g group, 5 g group |
Primary outcome
Diarrhoea and/or significant gastrointestinal (GI) symptoms
Time frame: 48 hours
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
4 secondary outcomes
Stool frequency
Time frame: 48 hours
Stool consistency
Time frame: 48 hours
Gastrointestinal symptoms
Time frame: 24 hours
Urinary erythritol excretion
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Background: PubMed 8933644Bornet 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.
- Background: PubMed 16277764Arrigoni 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.
- Background: PubMed 8933646Bornet 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.
- Background: PubMed 8933645Tetzloff 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.
- Background: PubMed 9862657Munro 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.
- Background: PubMed 16988647Storey 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.
- Background: PubMed 1578324Lifshitz 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.
- Background: PubMed 9299672Lewis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelyne Jacqz-Aigrain, PhD principal investigator
Clinical Investigation Centre Robert Debré Hospital, Paris, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erythritol drink in people with Gastrointestinal and Tolerance, run by Cargill at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diarrhoea and/or significant gastrointestinal (GI) symptoms (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02016703, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.