ToleranceNCT05794100
Evaluating the Impact of Different Sugar Replacer Combinations on Gastrointestinal Tolerance
A study of Tolerance and Healthy Population, run by Mondelēz International, Inc. at 1 site in United States.
Trial summary
This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of 3 sugar replacers mixes at 3 different doses. The investigators will also try to understand the factors that could explain the presence or absence of symptoms Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tolerance, Healthy Population
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2021to 30 Jul 2022
- 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
- Male or female, 18-55 years of age, inclusive at Visit 1 (Day -11).
- BMI of 18.5 to 32.0 kg/m2, inclusive, at Visit 1 (Day -11).
- Have normal bowel movement habit (<3 bowel movements/d to >2 bowel movements/week) based on the BHD-BSS collected at Visit 2 (Day -4).
- Consumes fiber at an amount no more than the average American diet [based on consumption of high-fiber containing plant-based foods (e.g., fruits, vegetables, legumes, pulses, nuts, and products labeled as good or excellent sources of fiber)].
- Smokes 10 cigarettes or less in a day and has no plan to change nicotine habits during the study period.
- Non-user or former users (cessation ≥12 mo) of any marijuana or hemp products and has no plans to use marijuana or hemp products during the study period.
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- Willing to maintain habitual dietary, lifestyle, and physical activity (with exceptions per study instructions) throughout the trial and willing to adhere to dietary, lifestyle, and physical activity requirements of the study.
- Willing to limit alcohol consumption to ≤3 standard drinks/d and ≤7 standard drinks/week throughout the trial.
- Willing to refrain from exclusionary medications, supplements, and products throughout the study.
- No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
- Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
Who cannot join
- Moderate or severe GI symptoms or 3-d total score of >2 for any individual GI symptom based on the baseline GITQ collected at Visit 2 (Day -4). Mild burping and/or flatulence totaling a 3-d score of >2 is acceptable.
- Has a clinically significant GI-related reaction towards GI symptom-causing foods (e.g., beans and legumes, vegetables high in inulin, sodas or fruit drinks, sugar alcohols, inulin, fructooligosaccharides, gluten, and dairy products [see Appendix 3]) as judged by the Clinical Investigator.
- Female subjects who typically experience change in GI symptoms or bowel habits (e.g., increased or decreased laxation, bloating, abdominal cramping) at the time of menstruation. Subjects with these issues may be included if they are able to reliably predict the onset and duration of their menstruation-related symptoms (e.g., always occur only during the first two days of menses), in the judgment of the Clinical Investigator. Test visits will be scheduled around menses.
- Female subjects who is unwilling to wear a tampon during the collection of the 24-h urine samples when these collections occur during the time of menstruation.
- Abnormal laboratory test results of clinical significance at Visit 1 (Day -11), at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to Visit 2 (Day -4), for subjects with abnormal laboratory test results.
- Clinically important GI condition that would potentially interfere with the evaluation of the study products (e.g., inflammatory bowel disease, irritable bowel syndrome, gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies).
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- Recent (within 2 weeks of Visit 1; Day -11) history of an episode of acute GI illness such as nausea/vomiting or diarrhea (defined as ≥3 loose or liquid stools/d).
- Self-reported history (within 6 weeks of Visit 1; Day -11) of constipation or diarrhea at the discretion of the Clinical Investigator.
- Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders. Conditions which are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (Day -11). One re-test will be allowed on a separate day prior to Visit 2 (Day 0), for subjects whose blood pressure exceeds either of these cut points at Visit 1 (Day -11), in the judgment of the Clinical Investigator. If taken, the repeat blood pressure measurement will be used to determine eligibility. Stable use of hypertension medication is allowed [defined as no change in medication regimen within the 3 mo prior to Visit 1 (Day -11)].
- Any known food allergy as well as intolerance or sensitivity to study product ingredients (Appendix 13).
- Extreme dietary habits or physical activity patterns at the discretion of the Clinical Investigator.
- History or presence of cancer in the prior 2 y, except for non-melanoma skin cancer.
- Major trauma or any other surgical event within 3 mo of Visit 1 (Day -11).
- Signs or symptoms of an active infection of clinical relevance within 5 d of Visit 1 (Day -11). The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 d prior to Visit 1 (Day -11)*
- Weight loss or gain > 4.5 kg in the 3 mo prior to Visit 1 (Day -11).
- Currently or planning to be on a weight loss regimen during the study.
- Antibiotic, antifungal, or antiparasitic use within 3 mo of Visit 1 (Day -11) and throughout the study period.
- Use of steroids within 1 mo of Visit 1 (Day -11) and throughout the study period. Use of nasal and non-prescription topical treatments is allowed.
- Chronic use (i.e., daily on a regular basis) of anti-inflammatory medications (e.g., NSAIDS) within 1 mo of Visit 1 (Day -11).
- Use of medications (over-the-counter or prescription) and/or dietary supplements, known to influence GI function, including but not limited to prebiotics or probiotics, laxatives, enemas, fiber supplements and/or suppositories, antacids, anti-diarrheal agents, and/or anti-spasmodic within 3 weeks of Visit 1 (Day -11). Standard multivitamin and mineral supplements are allowed.
- Participated in endoscopy or endoscopy preparation within 3 mo prior to Visit 1 (Day -11).
- Exposure to any non-registered drug product within 4 weeks prior to Visit 1 (Day -11).
- Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. Subjects who are pregnant during the study will be discontinued.
- Recent history (within 12 mo of screening; Visit 1; Day -11) of alcohol or substance abuse. Alcohol abuse is defined as >14 drinks/week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Innovation Services
Addison, Illinois, 60101
About this study
This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of 3 sugar replacers mixes at 3 different doses. The investigators will also try to understand the factors that could explain the presence or absence of symptoms
Read the detailed description
This study is a randomized, double-blind, crossover trial with 23 visits consisting of one screening visit, one baseline visit, and 21 study visits (10 test periods each consisting of 2 test visits and one drop-off visit) across 11 weeks. For this study, 60 generally healthy subjects will be randomized to a test sequence and will consume one control product and nine test products over the course of the study. Before consumption of any study products, breath hydrogen lactulose assessment and collection of stool samples for microbiome analysis will be completed. Additionally, midway through the study, data will be reviewed in a blinded manner and a stool sample will be collected from a subset of 30 subjects for in vitro fermentation tests. Gastrointestinal symptoms and stool information will be collected using the Gastrointestinal Tolerance Questionnaire (GITQ) and Bowel Habit Diary with Bristol Stool Scale (BHD-BSS). The GITQ and BHD-BSS will be administered for 3 days and 7 days prior to study product consumption, respectively. Additionally, the GITQ and BHD-BSS will be collected throughout the day of study product consumption and the 2 days after product consumption. 24-h urine samples will be collected after study product consumption for urinary allulose analysis.
- Conditions
- Tolerance, Healthy Population
- Being tested
- Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator
- Keywords
- Sugar replacer, Gastrointestinal symptoms, GITQ, BHD-BSS, Acute, microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute intake of one of the products (active comparator 1 to 9) or Placebo comparatorOther
Also called No sugar chewable candies
One pack of each product (1 to 10) will be consumed on a separate occasion
| Study group | Role | What they receive |
|---|---|---|
| Test 1 | Active comparator | No-sugar chewable candy containing Soluble Corn Fiber + Inulin + Allulose provided at a dose of 1 serving equivalent Receives: Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator |
| Test 2 | Active comparator | No-sugar chewable candy containing Soluble Corn Fiber + Inulin + Allulose provided at a dose of 1.75 serving equivalent Receives: Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator |
| Test 3 | Active comparator | No-sugar chewable candy containing Soluble Corn Fiber + Inulin + Allulose provided at a dose of 2.5 serving equivalent Receives: Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator |
| Test 4 | Active comparator | No-sugar chewable candy containing Soluble Corn Fiber + Inulin + FOS provided at a dose of 1 serving equivalent Receives: Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator |
| Test 5 | Active comparator | No-sugar chewable candy containing Soluble Corn Fiber + Inulin + FOS provided at a dose of 1.75 serving equivalent Receives: Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator |
| Test 6 | Active comparator | No-sugar chewable candy containing Soluble Corn Fiber + Inulin + FOS provided at a dose of 2.5 serving equivalent Receives: Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator |
| Test 7 | Active comparator | No-sugar chewable candy containing Maltitol + Polydextrose provided at a dose of 1 serving equivalent Receives: Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator |
| Test 8 | Active comparator | No-sugar chewable candy containing Maltitol + Polydextrose provided at a dose of 1.75 serving equivalent Receives: Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator |
| Test 9 | Active comparator | No-sugar chewable candy containing Maltitol + Polydextrose provided at a dose of 2.5 serving equivalent Receives: Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator |
| Test 10 | Placebo comparator | Control chewable candy made with sugar and provided at a dose of 1 serving equivalent Receives: Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in area under the curve (AUC) of the composite Gastrointestinal symptom score of each test product versus control
AUC of the composite Gastrointestinal symptoms score based on GITQ (gastro-intestinal tolerance questionnaire)
Measured: AUC between 0 to 48 hours after intake of products
Secondary outcomes (13)
Difference in the continuous AUC of the composite GI symptom score between doses within each formulation
Area under the curve (AUC) of the composite GI symptoms score based on GITQ (gastro-intestinal tolerance questionnaire)
Measured: AUC between 0 to 48 hours after intake of products
Difference in the continuous AUC of the composite GI symptom score between formulations within each dose
AUC of the composite GI symptoms score based on GITQ
Measured: AUC between 0 to 48 hours after intake of products
Difference in the continuous AUC for each individual GI symptom score of test products as compared to control, dose within each formulation, and formulation within each dose
AUC of the composite GI symptoms score based on GITQ (gastro-intestinal tolerance questionnaire)
Measured: AUC between 0 to 48 hours after intake of products
Proportion of subjects who have a composite GI symptom score larger than 1 at each measured time point
AUC of the composite GI symptoms score based on GITQ (gastro-intestinal tolerance questionnaire)
Measured: AUC between 0 to 48 hours after intake of products
Proportion of subjects with diarrhea based on BHD-BSS (Bowel Habit Diary - Brictol Stool Scale)
diarrhea
Measured: Evaluation over 24 hours following intake of products
Proportion of subjects that report any (score >0) or moderate-to-severe (score >1) symptom at each measured time point for each individual outcome
Individual GI symptoms from GITQ (gastro-intestinal tolerance questionnaire)
Measured: Evaluation performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours
Summary of the maximum detected score for each individual GI symptom
Individual GI symptoms from GITQ (gastro-intestinal tolerance questionnaire)
Measured: Evaluation performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours
Summary of the time of the maximum detected score for each individual symptom
Individual GI symptoms from GITQ (gastro-intestinal tolerance questionnaire)
Measured: Evaluation performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours
Proportion of subjects that report any (score >0) or moderate-to-severe (score >1) bothersome loose stools on the GITQ at each measured time point
Loose stools from BHD-BSS (Bowel Habit Diary - Brictol Stool Scale)
Measured: Evaluation performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours
Difference between test and control products, between dose within each formulation, and between formulation within each dose for all parameters of the BHD-BSS (Bowel Habit Diary - Brictol Stool Scale)
Bowel movment characteristics from BHD-BSS (Bowel Habit Diary - Brictol Stool Scale)
Measured: At each bowel movement over 48 hours
Urinary allulose
Difference between test and control products, between dose (number of servings) within each formulation, and between formulation within each dose on urinary Allulose
Measured: Collect over 24 hours
Gut Microbiota composition
Microbial composition by sequencing
Measured: Baseline
Correlation analyses between microbiota composition and GITQ individual parameters
Mechanism of action
Measured: AUC 0 to 48 hours for composite scores and evaluations performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start11 Oct 2021
- Primary completion30 May 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Each subject will be allocated to a sequence of consumption of the 10 different products
- 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
- BioFortis
- Responsible party
- Sponsor
- Investigators
- Kathleen M Kelley, MD, Principal investigator, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794100
- Sponsor's protocol ID
- KBE062 / BIO-2110
- Status last verified
- Mar 2023
- First submitted
- 25 Nov 2021
- Last updated
- 3 Apr 2023
- 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 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Different Sugar Replacer Combinations on Gastrointestinal Tolerance
- ClinicalTrials.gov ID
- NCT05794100
- Acronym / sponsor ID
- KBE062 / BIO-2110
- Conditions
- Tolerance, Healthy Population
- Keywords
- Sugar replacer, Gastrointestinal symptoms, GITQ, BHD-BSS, Acute, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 3 Apr 2023 (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 3 sugar replacers mixes at 3 different doses. The investigators will also try to understand the factors that could explain the presence or absence of symptoms
Detailed description
This study is a randomized, double-blind, crossover trial with 23 visits consisting of one screening visit, one baseline visit, and 21 study visits (10 test periods each consisting of 2 test visits and one drop-off visit) across 11 weeks. For this study, 60 generally healthy subjects will be randomized to a test sequence and will consume one control product and nine test products over the course of the study. Before consumption of any study products, breath hydrogen lactulose assessment and collection of stool samples for microbiome analysis will be completed. Additionally, midway through the study, data will be reviewed in a blinded manner and a stool sample will be collected from a subset of 30 subjects for in vitro fermentation tests. Gastrointestinal symptoms and stool information will be collected using the Gastrointestinal Tolerance Questionnaire (GITQ) and Bowel Habit Diary with Bristol Stool Scale (BHD-BSS). The GITQ and BHD-BSS will be administered for 3 days and 7 days prior to study product consumption, respectively. Additionally, the GITQ and BHD-BSS will be collected throughout the day of study product consumption and the 2 days after product consumption. 24-h urine samples will be collected after study product consumption for urinary allulose analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 10
- Model description
- Each subject will be allocated to a sequence of consumption of the 10 different products
| Arm | Type | Receives |
|---|---|---|
| Test 1 | Active comparator | Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparatorNo-sugar chewable candy containing Soluble Corn Fiber + Inulin + Allulose provided at a dose of 1 serving equivalent |
| Test 2 | Active comparator | Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparatorNo-sugar chewable candy containing Soluble Corn Fiber + Inulin + Allulose provided at a dose of 1.75 serving equivalent |
| Test 3 | Active comparator | Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparatorNo-sugar chewable candy containing Soluble Corn Fiber + Inulin + Allulose provided at a dose of 2.5 serving equivalent |
| Test 4 | Active comparator | Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparatorNo-sugar chewable candy containing Soluble Corn Fiber + Inulin + FOS provided at a dose of 1 serving equivalent |
| Test 5 | Active comparator | Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparatorNo-sugar chewable candy containing Soluble Corn Fiber + Inulin + FOS provided at a dose of 1.75 serving equivalent |
| Test 6 | Active comparator | Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparatorNo-sugar chewable candy containing Soluble Corn Fiber + Inulin + FOS provided at a dose of 2.5 serving equivalent |
| Test 7 | Active comparator | Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparatorNo-sugar chewable candy containing Maltitol + Polydextrose provided at a dose of 1 serving equivalent |
| Test 8 | Active comparator | Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparatorNo-sugar chewable candy containing Maltitol + Polydextrose provided at a dose of 1.75 serving equivalent |
| Test 9 | Active comparator | Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparatorNo-sugar chewable candy containing Maltitol + Polydextrose provided at a dose of 2.5 serving equivalent |
| Test 10 | Placebo comparator | Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparatorControl chewable candy made with sugar and provided at a dose of 1 serving equivalent |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female, 18-55 years of age, inclusive at Visit 1 (Day -11).
- BMI of 18.5 to 32.0 kg/m2, inclusive, at Visit 1 (Day -11).
- Have normal bowel movement habit (<3 bowel movements/d to >2 bowel movements/week) based on the BHD-BSS collected at Visit 2 (Day -4).
- Consumes fiber at an amount no more than the average American diet [based on consumption of high-fiber containing plant-based foods (e.g., fruits, vegetables, legumes, pulses, nuts, and products labeled as good or excellent sources of fiber)].
- Smokes 10 cigarettes or less in a day and has no plan to change nicotine habits during the study period.
Key exclusion criteria (26 listed)
- Moderate or severe GI symptoms or 3-d total score of >2 for any individual GI symptom based on the baseline GITQ collected at Visit 2 (Day -4). Mild burping and/or flatulence totaling a 3-d score of >2 is acceptable.
- Has a clinically significant GI-related reaction towards GI symptom-causing foods (e.g., beans and legumes, vegetables high in inulin, sodas or fruit drinks, sugar alcohols, inulin, fructooligosaccharides, gluten, and dairy products [see Appendix 3]) as judged by the Clinical Investigator.
- Female subjects who typically experience change in GI symptoms or bowel habits (e.g., increased or decreased laxation, bloating, abdominal cramping) at the time of menstruation. Subjects with these issues may be included if they are able to reliably predict the onset and duration of their menstruation-related symptoms (e.g., always occur only during the first two days of menses), in the judgment of the Clinical Investigator. Test visits will be scheduled around menses.
- Female subjects who is unwilling to wear a tampon during the collection of the 24-h urine samples when these collections occur during the time of menstruation.
- Abnormal laboratory test results of clinical significance at Visit 1 (Day -11), at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to Visit 2 (Day -4), for subjects with abnormal laboratory test results.
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 |
|---|---|---|
| Acute intake of one of the products (active comparator 1 to 9) or Placebo comparatorAlso: No sugar chewable candiesOne pack of each product (1 to 10) will be consumed on a separate occasion | Other | Test 1, Test 10, Test 2, Test 3, Test 4, Test 5, Test 6, Test 7, Test 8, Test 9 |
Primary outcome
Difference in area under the curve (AUC) of the composite Gastrointestinal symptom score of each test product versus control
Time frame: AUC between 0 to 48 hours after intake of products
AUC of the composite Gastrointestinal symptoms score based on GITQ (gastro-intestinal tolerance questionnaire)
13 secondary outcomes
Difference in the continuous AUC of the composite GI symptom score between doses within each formulation
Time frame: AUC between 0 to 48 hours after intake of products
Difference in the continuous AUC of the composite GI symptom score between formulations within each dose
Time frame: AUC between 0 to 48 hours after intake of products
Difference in the continuous AUC for each individual GI symptom score of test products as compared to control, dose within each formulation, and formulation within each dose
Time frame: AUC between 0 to 48 hours after intake of products
Proportion of subjects who have a composite GI symptom score larger than 1 at each measured time point
Time frame: AUC between 0 to 48 hours after intake of products
Proportion of subjects with diarrhea based on BHD-BSS (Bowel Habit Diary - Brictol Stool Scale)
Time frame: Evaluation over 24 hours following intake of products
Proportion of subjects that report any (score >0) or moderate-to-severe (score >1) symptom at each measured time point for each individual outcome
Time frame: Evaluation performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours
Summary of the maximum detected score for each individual GI symptom
Time frame: Evaluation performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours
Summary of the time of the maximum detected score for each individual symptom
Time frame: Evaluation performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours
Proportion of subjects that report any (score >0) or moderate-to-severe (score >1) bothersome loose stools on the GITQ at each measured time point
Time frame: Evaluation performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours
Difference between test and control products, between dose within each formulation, and between formulation within each dose for all parameters of the BHD-BSS (Bowel Habit Diary - Brictol Stool Scale)
Time frame: At each bowel movement over 48 hours
Urinary allulose
Time frame: Collect over 24 hours
Gut Microbiota composition
Time frame: Baseline
Correlation analyses between microbiota composition and GITQ individual parameters
Time frame: AUC 0 to 48 hours for composite scores and evaluations performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 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 3 Apr 2023.
- 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.
Kathleen M Kelley, MD principal investigator
BioFortis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Tolerance and Healthy Population, run by Mondelēz International, Inc. at 1 site in United States.
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 11 inclusion and 26 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 3 Apr 2023. 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 United States. 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?
Difference in area under the curve (AUC) of the composite Gastrointestinal symptom score of each test product versus control (time frame: AUC between 0 to 48 hours after intake of products). 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 3 Apr 2023.