Gastrointestinal ToleranceNCT06479330
Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Chocolate
A study testing Milk Chocolate in people with Gastrointestinal Tolerance and Healthy Population, run by Mondelēz International, Inc. at 1 site in Canada.
Trial summary
This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of sugar replacer ingredients and blends (maltitol, kestose (Oligofructose), kestose + cocoa and polydextrose premix at different doses) Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tolerance, Healthy Population
- What is being tested?
- Milk Chocolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jul 2024to 20 Dec 2024
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-pregnant, non-lactating, healthy individuals aged 18-55 years, inclusive
- Body Mass Index (BMI) 18.5-32.0kg/m², inclusive
- No major illness, trauma or surgery requiring hospitalization within 3 months of the screening visit
- Ability to understand the study procedures and willing to provide informed consent to participate in the study
- Non-smokers or smokers who smoke <10 cigarettes/day and are willing not to change nicotine habits during the study period
- Willing to limit alcohol consumption to ≤3 standard drinks/day and ≤7 standard drinks/week during the study period
Show all 12Show fewer
- Willing to refrain from any marijuana or hemp products during the study period
- Normal bowel habits (>2 bowel movements/week and <3 bowel movements per day)
- Consumes ≤4 servings/day of fruits and vegetables combined and ≤3 (women) or ≤4 (men) servings/day of whole grains using the definitions of "serving" .
- Participants must have a cell phone/tablet/computer and be willing and able to use it to collect study data
- Participants must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP (Ontario Health Insurance Plan)
- Participants are willing to follow current COVID guidelines with respect to attending study visits
Who cannot join
- Failure to meet any one of the inclusion criteria
- Chronic moderate to severe gastrointestinal symptoms
- Use of systemic antibiotics, antifungals or antiparasitics in the past 3 months and during the experimental period
- Use of medications, supplements, and products which may affect the results (laxative, anti-diarrhea, anti-constipation drugs, high fiber supplements)
- Individuals with any medical conditions or use of supplements or medications that increase risk to the subject or others or may affect the results, as judged by the Principal - Investigator
- Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines
- Known intolerance, sensitivity, or allergy to any ingredients in the study test products
- Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification
Trial locations and contacts
1 site in 1 country.
About this study
This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of sugar replacer ingredients and blends (maltitol, kestose (Oligofructose), kestose + cocoa and polydextrose premix at different doses)
Read the detailed description
The study will have a randomized, double-blind, crossover design with 5 visits consisting of one screening visit and 5 study visits (3-14-day interval between the start of each visit) across 2-8 weeks. Participants will be randomized to a test sequence and will consume one control product and 4 test products made with the sugar replacer ingredients or blend of ingredients over the course of the study. At each visit, eligible participants will come to the lab between 8-11am, and ~1-2 hours after consuming their usual breakfast at home. After rating the severity of gastrointestinal symptoms, participants will consume one of the investigational products with a drink of water (250ml) and then be free to leave. The severity of 8 gastrointestinal symptoms (abdominal bloating, abdominal pain, flatulence, burping, reflux (heartburn), stomach rumbling (borborygmus), nausea and vomiting) will be rated at 2, 4, 6, 10 and 24 hours after starting to eat. Over the 24 hour period following consuming the investigational product a Bowel Habit Diary will be kept. For each bowel movement passed during the 24 hour period, participants will be asked to record: the time, if they had to strain, if they experienced discomfort, if they felt there was incomplete evacuation and the consistency of the stool rated using the Bristol Stool Scale (BSS).
- Conditions
- Gastrointestinal Tolerance, Healthy Population
- Being tested
- Milk Chocolate
- Keywords
- sugar replacers, gastrointestinal symptoms, Bowel Habits Diary - Bristol Stool Scale (BHD-BSS), Gastrointestinal Tolerance Questionnaire (GITQ), Acute, Chocolate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk ChocolateOther
Acute intake
| Study group | Role | What they receive |
|---|---|---|
| Control chocolate with sugar | Placebo comparator | Milk chocolate made with sugar at a dose of 45 g (2 servings) Receives: Other: Milk Chocolate |
| Maltitol chocolate | Active comparator | Milk chocolate with maltitol replacing all sugar at a dose of 45 g (2 servings) Receives: Other: Milk Chocolate |
| Kestose chocolate | Active comparator | Milk chocolate with kestose oligofructose replacing all sugar at a dose of 45 g (2 servings) Receives: Other: Milk Chocolate |
| Kestose + cocoa and polydextrose premix dose 1 chocolate | Active comparator | Millk chocolate with kestose oligofructose + cocoa and polydextrose premix dose 1 replacing all sugar at a dose of 45 g (2 servings) Receives: Other: Milk Chocolate |
| Kestose + cocoa and polydextrose premix dose 2 chocolate | Active comparator | Millk chocolate with kestose oligofructose + cocoa and polydextrose premix dose 2 replacing all sugar at a dose of 45 g (2 servings) Receives: Other: Milk Chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score
total area under the curve (tAUC) of the composite GastroIntestinal symptom score (sum of the scores for the 8 GI symptoms). The score values can range from 0 up to 24 with the higher values showing the higher levels of symptoms (worse conditions).
Measured: tAUC between 0 and 24 hours
Secondary outcomes (32)
Total Area Under the Curve of each individual gastrointestinal symptom
Total Area Under the Curve of each of the individual 8 gastrointestinal symptoms (abdominal bloating, abdominal pain, flatulence, burping, reflux, stomach rumbling, nausea, vomiting). Each symptom range from 0 up to 3 with 3 showing the highest / worse condiiton of symptoms
Measured: tAUC between 0 and 24 hours
Frequency of composite score > 1 at each time point
Proportion of participants who have a composite GastoInestinal symptom score >1 (moderate-to-severe) at each time point. The composite score can range from 0 up to 24 with the higher values showing the higher levels of symptoms (worse conditions)
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Frequency of Diarrhea within 24 hours
Proportion of participants with diarrhea, defined as 3 or more type 6 or 7 stools (based on the BSS) within the 24 hour period after consumption of the study products
Measured: Evaluation performed over 24 hour after consumption of study products
Time for maximum score for abdominal bloating
Time of the maximum score
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for abdominal bloating
Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for abdominal bloating
Maximum detected score (which can range from 0 up to 3)
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for abdominal pain
Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for abdominal pain
Maximum detected score (which can range from 0 up to 3)
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time of maximum score for abdominal pain
Time of the maximum score
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for flatulence
Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for flatulence
Maximum detected score (which can range from 0 up to 3)
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for flatulence
Time of the maximum score
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for burping
Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for burping
Maximum detected score (which can range from 0 up to 3)
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for burping
Time of the maximum score
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for reflux
Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for reflux
Maximum detected score (which can range from 0 up to 3)
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for reflux
Time of the maximum score
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for stomach rumbling
Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for stomach rumbling
Maximum detected score (which can range from 0 up to 3)
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for stomach rumbling
Time of the maximum score
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for nausea
Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for nausea
Maximum detected score (which can range from 0 up to 3)
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for nausea
Time of the maximum score
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for vomiting
Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for vomiting
Maximum detected score (which can range from 0 up to 3)
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for vomiting
Time of the maximum score
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Number of bowel movements
Number of bowel movements over the 24 hours
Measured: Evaluation performed over 24 hour after consumption of study products
straining during bowel movement
Proportion of participants having to strain or not
Measured: Evaluation performed over 24 hour after consumption of study products
discomfort during bowel movement
Proportion of participants having discomfort or not
Measured: Evaluation performed over 24 hour after consumption of study products
incomplete evacuation
Proportion of participants declaring incomplete evacuation or not
Measured: Evaluation performed over 24 hour after consumption of study products
Stool consistency based on bristol stool scale
mean stool consistency on Bristol Stool Scale (BSS). The scale provide values from 1 to 7 depending on the type of stool with 1 being the driest stools and 7 the most liquid one.
Measured: Evaluation performed over 24 hour after consumption of study products
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start9 Jul 2024
- Primary completion16 Oct 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ToleranceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In a 5-way cross-over, there is a set of 10 balanced sequences to which participants will be randomly assigned. Blocks of 1 or 2 sets of sequences will be randomly ordered to create a balanced sequence for n=60 participants. Orders will be assigned to participants in the order they attended for the first visit after being recruited.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479330
- Sponsor's protocol ID
- KBE070 / INQ-2402
- Status last verified
- Mar 2026
- First submitted
- 19 Jun 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Chocolate
- ClinicalTrials.gov ID
- NCT06479330
- Acronym / sponsor ID
- KBE070 / INQ-2402
- Conditions
- Gastrointestinal Tolerance, Healthy Population
- Keywords
- sugar replacers, gastrointestinal symptoms, Bowel Habits Diary - Bristol Stool Scale (BHD-BSS), Gastrointestinal Tolerance Questionnaire (GITQ), Acute, Chocolate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 28 Jun 2024 (actual)
- 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.
This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of sugar replacer ingredients and blends (maltitol, kestose (Oligofructose), kestose + cocoa and polydextrose premix at different doses)
Detailed description
The study will have a randomized, double-blind, crossover design with 5 visits consisting of one screening visit and 5 study visits (3-14-day interval between the start of each visit) across 2-8 weeks. Participants will be randomized to a test sequence and will consume one control product and 4 test products made with the sugar replacer ingredients or blend of ingredients over the course of the study. At each visit, eligible participants will come to the lab between 8-11am, and ~1-2 hours after consuming their usual breakfast at home. After rating the severity of gastrointestinal symptoms, participants will consume one of the investigational products with a drink of water (250ml) and then be free to leave. The severity of 8 gastrointestinal symptoms (abdominal bloating, abdominal pain, flatulence, burping, reflux (heartburn), stomach rumbling (borborygmus), nausea and vomiting) will be rated at 2, 4, 6, 10 and 24 hours after starting to eat. Over the 24 hour period following consuming the investigational product a Bowel Habit Diary will be kept. For each bowel movement passed during the 24 hour period, participants will be asked to record: the time, if they had to strain, if they experienced discomfort, if they felt there was incomplete evacuation and the consistency of the stool rated using the Bristol Stool Scale (BSS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- In a 5-way cross-over, there is a set of 10 balanced sequences to which participants will be randomly assigned. Blocks of 1 or 2 sets of sequences will be randomly ordered to create a balanced sequence for n=60 participants. Orders will be assigned to participants in the order they attended for the first visit after being recruited.
| Arm | Type | Receives |
|---|---|---|
| Control chocolate with sugar | Placebo comparator | Other: Milk ChocolateMilk chocolate made with sugar at a dose of 45 g (2 servings) |
| Maltitol chocolate | Active comparator | Other: Milk ChocolateMilk chocolate with maltitol replacing all sugar at a dose of 45 g (2 servings) |
| Kestose chocolate | Active comparator | Other: Milk ChocolateMilk chocolate with kestose oligofructose replacing all sugar at a dose of 45 g (2 servings) |
| Kestose + cocoa and polydextrose premix dose 1 chocolate | Active comparator | Other: Milk ChocolateMillk chocolate with kestose oligofructose + cocoa and polydextrose premix dose 1 replacing all sugar at a dose of 45 g (2 servings) |
| Kestose + cocoa and polydextrose premix dose 2 chocolate | Active comparator | Other: Milk ChocolateMillk chocolate with kestose oligofructose + cocoa and polydextrose premix dose 2 replacing all sugar at a dose of 45 g (2 servings) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Non-pregnant, non-lactating, healthy individuals aged 18-55 years, inclusive
- Body Mass Index (BMI) 18.5-32.0kg/m², inclusive
- No major illness, trauma or surgery requiring hospitalization within 3 months of the screening visit
- Ability to understand the study procedures and willing to provide informed consent to participate in the study
- Non-smokers or smokers who smoke <10 cigarettes/day and are willing not to change nicotine habits during the study period
Key exclusion criteria (8 listed)
- Failure to meet any one of the inclusion criteria
- Chronic moderate to severe gastrointestinal symptoms
- Use of systemic antibiotics, antifungals or antiparasitics in the past 3 months and during the experimental period
- Use of medications, supplements, and products which may affect the results (laxative, anti-diarrhea, anti-constipation drugs, high fiber supplements)
- Individuals with any medical conditions or use of supplements or medications that increase risk to the subject or others or may affect the results, as judged by the Principal - Investigator
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 |
|---|---|---|
| Milk ChocolateAcute intake | Other | Control chocolate with sugar, Kestose + cocoa and polydextrose premix dose 1 chocolate, Kestose + cocoa and polydextrose premix dose 2 chocolate, Kestose chocolate, Maltitol chocolate |
Primary outcome
Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score
Time frame: tAUC between 0 and 24 hours
total area under the curve (tAUC) of the composite GastroIntestinal symptom score (sum of the scores for the 8 GI symptoms). The score values can range from 0 up to 24 with the higher values showing the higher levels of symptoms (worse conditions).
32 secondary outcomes
Total Area Under the Curve of each individual gastrointestinal symptom
Time frame: tAUC between 0 and 24 hours
Frequency of composite score > 1 at each time point
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Frequency of Diarrhea within 24 hours
Time frame: Evaluation performed over 24 hour after consumption of study products
Time for maximum score for abdominal bloating
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for abdominal bloating
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for abdominal bloating
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for abdominal pain
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for abdominal pain
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time of maximum score for abdominal pain
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for flatulence
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for flatulence
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for flatulence
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for burping
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for burping
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for burping
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for reflux
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for reflux
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for reflux
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for stomach rumbling
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for stomach rumbling
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for stomach rumbling
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for nausea
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for nausea
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for nausea
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for vomiting
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for vomiting
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for vomiting
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Number of bowel movements
Time frame: Evaluation performed over 24 hour after consumption of study products
straining during bowel movement
Time frame: Evaluation performed over 24 hour after consumption of study products
discomfort during bowel movement
Time frame: Evaluation performed over 24 hour after consumption of study products
incomplete evacuation
Time frame: Evaluation performed over 24 hour after consumption of study products
Stool consistency based on bristol stool scale
Time frame: Evaluation performed over 24 hour after consumption of study products
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 1 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk Chocolate in people with Gastrointestinal Tolerance and Healthy Population, run by Mondelēz International, Inc. at 1 site in Canada.
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 12 inclusion and 8 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 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. Some participants in this study may receive a placebo. 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?
Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score (time frame: tAUC between 0 and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2026.