Intestinal GasNCT05510778
Effects of CharcoCaps® (Activated Charcoal) vs. Placebo on Intestinal Gas Production
A study testing Charcocaps in people with Intestinal Gas, run by University of Memphis at 1 site in United States.
Trial summary
Consumption of a high-fiber diet, often consisting of beans and vegetables, is recommended for improvements in overall health. Unfortunately, intake of the above-mentioned foods is often associated with a significant increase in intestinal gas production. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Gas
- What is being tested?
- Charcocaps
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2021to 22 Dec 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-report of at least one of the following symptoms after eating meals rich in complex carbohydrates (such as beans):
- Abdominal bloating/pain/cramps
- Flatulence/gas
- Willing to consume a meatless chili meal and steamed broccoli
- No consumption of alcohol-containing beverages within 24 hours of testing
- No consumption of caffeine-containing beverages within 24 hours of testing
- No strenuous exercise within 24 hours of testing
- Be able to fast overnight (>10 hrs)
Who cannot join
- Diagnosed GI condition
- Diabetic
- Pregnant/lactating
- Self-reported active infection or illness of any kind
- Tobacco product user
- Hypersensitivity or allergy to any component of the supplement or chili (Activated charcoal, Gelatin, Titanium Dioxide, and Carmine, black beans, kidney beans, pinto beans, tomato puree, bell peppers, onion, sweet potato, chili powder, onion powder, garlic powder, salt, pepper, cumin, oregano, broccoli)
- Taking any anti-gas, or anti-flatulence medication or dietary supplements, or if taking only non-prescribed supplements/mediations, not willing to cease use of them during study period
- A regular consumer of bean meals (no more than once weekly)
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38152
About this study
Official title: Effects of CharcoCaps® (Activated Charcoal) vs. Placebo on Intestinal Gas Production Assessed Using Breath Hydrogen and a Gastrointestinal Questionnaire
Consumption of a high-fiber diet, often consisting of beans and vegetables, is recommended for improvements in overall health. Unfortunately, intake of the above-mentioned foods is often associated with a significant increase in intestinal gas production. In addition to gas, abdominal bloating, cramping, and associated symptoms can prove unacceptable-leading people to limit or abandon the consumption of bean-rich meals.
In an attempt to reduce gas formation and the ensuing symptoms, various anti-gas products have been developed and are sold on the market. One such non-prescription product is Beano, a solution of the enzyme alpha-galactosidase. In addition to alpha-galactosidase, activated charcoal has also been used successfully in some, but not all, studies and may be a good option for certain individuals.
CharcoCaps® is a branded form of activated charcoal that has been sold for several years.That said, no controlled studies have been conducted using CharcoCaps®. This study will investigate the effects of ingesting CharcoCaps® before and following the meal on the amount of gas produced, the number of flatus events, and associated symptoms of GI distress during the 6-hour post meal ingestion period.
Read the detailed description
Consumption of a high-fiber diet, often consisting of beans and vegetables, is recommended for improvements in overall health. Adhering to such a dietary regimen is associated with weight management, as well as improvements in the blood lipid profile and glucose regulation (i.e., the prevention of type 2 diabetes). The end result is a lowering of the overall risk of cardio-metabolic disease .
Unfortunately, intake of the above mentioned foods is often associated with a significant increase in intestinal gas production, which has been suggested to be upwards of 10x that of a non-gas producing diet. This can be both uncomfortable and embarrassing when in social situations. In particular, flatus events are increased as a result of consumption of a bean-rich diet, with large volumes of flatus produced shortly after the ingestion of meals (within a few hours). In addition to flatus, abdominal bloating, cramping, and associated symptoms can prove unacceptable-leading people to limit or abandon the consumption of bean-rich meals.
In an attempt to reduce gas formation and the ensuing symptoms, various anti-gas products have been developed and are sold on the market. One such non-prescription product is Beano, a solution of the enzyme alpha-galactosidase. This product has been reported to effectively lower gas production (as evidenced by flatus events) following the consumption of a meatless chili meal, with the greatest improvements noted between 4-6 hours post meal ingestion.
In addition to alpha-galactosidase, activated charcoal has also been used successfully in some, but not all, studies and may be a good option for certain individuals. Activated charcoal is a fine, odorless powder formed from the destructive distillation of various organic materials, treated with substances such as steam or other chemicals at very high temperatures to increase its absorptive power. This agent is often described as a "rigid sponge" and has the ability to absorb many chemical substances, including gases. In fact, some have suggested that adding charcoal inside the seat cushions on airplanes may improve the flight experience for passengers, as released gas could be captured by the charcoal within the seats and reduce the odor.
CharcoCaps® is a branded form of activated charcoal that has been sold for several years, is widely available (e.g., Amazon, Walgreens, CVS), and has received excellent reviews from end users with regards to its ability to reduce intestinal gas production. That said, no controlled studies have been conducted using CharcoCaps®. Therefore, the following study will be conducted using a double-blind, placebo controlled, cross-over design to determine the impact of CharcoCaps® to reduce gas production and associated symptoms following the ingestion of a bean-rich meal. The investigators hypothesize that ingestion of CharcoCaps® before and following the meal will reduce the amount of gas produced, the number of flatus events, as well as associated symptoms of GI distress during the 6-hour post meal ingestion period.
- Conditions
- Intestinal Gas
- Being tested
- Charcocaps, Placebo
- Keywords
- Charcocaps, Intestinal gas, Breath Hydrogen
- Medical subject headings
- Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CharcocapsDietary supplement
250 mg capsules containing Activated charcoal, Gelatin, Titanium Dioxide, and Carmine
PlaceboOther
capsules containing ~250 mg cellulose
| Study group | Role | What they receive |
|---|---|---|
| Charcocaps | Experimental | 2 capsules 15 minutes before meal and 2 additional capsules 2 hours after meal Receives: Dietary Supplement: Charcocaps |
| Placebo | Placebo comparator | 2 capsules 15 minutes before meal and 2 additional capsules 2 hours after meal Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
Measured: 0 minutes before chili meal consumed (baseline)
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
Measured: 30 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
Measured: 60 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
Measured: 90 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
Measured: 120 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
Measured: 150 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
Measured: 180 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
Measured: 210 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
Measured: 240 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
Measured: 270 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
Measured: 300 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
Measured: 330 minutes post meal consumption
Breath Hydrogen
Hydrogen measured in exhale using H2 Check Analyzer
Measured: 360 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Measured: baseline
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Measured: 30 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Measured: 60 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Measured: 90 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Measured: 120 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Measured: 150 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Measured: 180 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Measured: 210 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Measured: 240 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Measured: 270 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Measured: 300 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Measured: 330 minutes post meal consumption
Gastrointestinal Symptoms Questionnaire
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Measured: 360 minutes post meal consumption
Flatus events
Self-reported number of flatus events each hour
Measured: baseline
Flatus events
Self-reported number of flatus events each hour
Measured: 60 minutes post meal consumption
Flatus events
Self-reported number of flatus events each hour
Measured: 120 minutes post meal consumption
Flatus events
Self-reported number of flatus events each hour
Measured: 180 minutes post meal consumption
Flatus events
Self-reported number of flatus events each hour
Measured: 240 minutes post meal consumption
Flatus events
Self-reported number of flatus events each hour
Measured: 300 minutes post meal consumption
Flatus events
Self-reported number of flatus events each hour
Measured: 360 minutes post meal consumption
Secondary outcomes (1)
Concluding Questionnaire
Questionnaire where subjects provide written feedback on their perceptions of the assigned condition
Measured: 60 minutes post meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start30 Sep 2021
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal GasStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double-blind, placebo controlled, cross-over
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- DSE Healthcare Solutions
- Responsible party
- Principal investigator, Richard Bloomer, University of Memphis
- Investigators
- Richard Bloomer, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510778
- Sponsor's protocol ID
- PRO-FY2022-9
- Status last verified
- Aug 2022
- First submitted
- 8 Dec 2021
- Last updated
- 22 Aug 2022
- 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 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of CharcoCaps® (Activated Charcoal) vs. Placebo on Intestinal Gas Production Assessed Using Breath Hydrogen and a Gastrointestinal Questionnaire
- ClinicalTrials.gov ID
- NCT05510778
- Acronym / sponsor ID
- PRO-FY2022-9
- Conditions
- Intestinal Gas
- Keywords
- Charcocaps, Intestinal gas, Breath Hydrogen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- DSE Healthcare Solutions
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 22 Aug 2022 (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.
Consumption of a high-fiber diet, often consisting of beans and vegetables, is recommended for improvements in overall health. Unfortunately, intake of the above-mentioned foods is often associated with a significant increase in intestinal gas production. In addition to gas, abdominal bloating, cramping, and associated symptoms can prove unacceptable-leading people to limit or abandon the consumption of bean-rich meals.
In an attempt to reduce gas formation and the ensuing symptoms, various anti-gas products have been developed and are sold on the market. One such non-prescription product is Beano, a solution of the enzyme alpha-galactosidase. In addition to alpha-galactosidase, activated charcoal has also been used successfully in some, but not all, studies and may be a good option for certain individuals.
CharcoCaps® is a branded form of activated charcoal that has been sold for several years.That said, no controlled studies have been conducted using CharcoCaps®. This study will investigate the effects of ingesting CharcoCaps® before and following the meal on the amount of gas produced, the number of flatus events, and associated symptoms of GI distress during the 6-hour post meal ingestion period.
Detailed description
Consumption of a high-fiber diet, often consisting of beans and vegetables, is recommended for improvements in overall health. Adhering to such a dietary regimen is associated with weight management, as well as improvements in the blood lipid profile and glucose regulation (i.e., the prevention of type 2 diabetes). The end result is a lowering of the overall risk of cardio-metabolic disease .
Unfortunately, intake of the above mentioned foods is often associated with a significant increase in intestinal gas production, which has been suggested to be upwards of 10x that of a non-gas producing diet. This can be both uncomfortable and embarrassing when in social situations. In particular, flatus events are increased as a result of consumption of a bean-rich diet, with large volumes of flatus produced shortly after the ingestion of meals (within a few hours). In addition to flatus, abdominal bloating, cramping, and associated symptoms can prove unacceptable-leading people to limit or abandon the consumption of bean-rich meals.
In an attempt to reduce gas formation and the ensuing symptoms, various anti-gas products have been developed and are sold on the market. One such non-prescription product is Beano, a solution of the enzyme alpha-galactosidase. This product has been reported to effectively lower gas production (as evidenced by flatus events) following the consumption of a meatless chili meal, with the greatest improvements noted between 4-6 hours post meal ingestion.
In addition to alpha-galactosidase, activated charcoal has also been used successfully in some, but not all, studies and may be a good option for certain individuals. Activated charcoal is a fine, odorless powder formed from the destructive distillation of various organic materials, treated with substances such as steam or other chemicals at very high temperatures to increase its absorptive power. This agent is often described as a "rigid sponge" and has the ability to absorb many chemical substances, including gases. In fact, some have suggested that adding charcoal inside the seat cushions on airplanes may improve the flight experience for passengers, as released gas could be captured by the charcoal within the seats and reduce the odor.
CharcoCaps® is a branded form of activated charcoal that has been sold for several years, is widely available (e.g., Amazon, Walgreens, CVS), and has received excellent reviews from end users with regards to its ability to reduce intestinal gas production. That said, no controlled studies have been conducted using CharcoCaps®. Therefore, the following study will be conducted using a double-blind, placebo controlled, cross-over design to determine the impact of CharcoCaps® to reduce gas production and associated symptoms following the ingestion of a bean-rich meal. The investigators hypothesize that ingestion of CharcoCaps® before and following the meal will reduce the amount of gas produced, the number of flatus events, as well as associated symptoms of GI distress during the 6-hour post meal ingestion period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double-blind, placebo controlled, cross-over
| Arm | Type | Receives |
|---|---|---|
| Charcocaps | Experimental | Dietary Supplement: Charcocaps2 capsules 15 minutes before meal and 2 additional capsules 2 hours after meal |
| Placebo | Placebo comparator | Other: Placebo2 capsules 15 minutes before meal and 2 additional capsules 2 hours after meal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Self-report of at least one of the following symptoms after eating meals rich in complex carbohydrates (such as beans):
- Willing to consume a meatless chili meal and steamed broccoli
- No consumption of alcohol-containing beverages within 24 hours of testing
- No consumption of caffeine-containing beverages within 24 hours of testing
- No strenuous exercise within 24 hours of testing
Key exclusion criteria (8 listed)
- Diagnosed GI condition
- Diabetic
- Pregnant/lactating
- Self-reported active infection or illness of any kind
- Tobacco product user
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 |
|---|---|---|
| Charcocaps250 mg capsules containing Activated charcoal, Gelatin, Titanium Dioxide, and Carmine | Dietary supplement | Charcocaps |
| Placebocapsules containing ~250 mg cellulose | Other | Placebo |
Primary outcome
Breath Hydrogen
Time frame: 0 minutes before chili meal consumed (baseline)
Hydrogen measured in exhale using H2 Check Analyzer
Breath Hydrogen
Time frame: 30 minutes post meal consumption
Hydrogen measured in exhale using H2 Check Analyzer
Breath Hydrogen
Time frame: 60 minutes post meal consumption
Hydrogen measured in exhale using H2 Check Analyzer
Breath Hydrogen
Time frame: 90 minutes post meal consumption
Hydrogen measured in exhale using H2 Check Analyzer
Breath Hydrogen
Time frame: 120 minutes post meal consumption
Hydrogen measured in exhale using H2 Check Analyzer
Breath Hydrogen
Time frame: 150 minutes post meal consumption
Hydrogen measured in exhale using H2 Check Analyzer
Breath Hydrogen
Time frame: 180 minutes post meal consumption
Hydrogen measured in exhale using H2 Check Analyzer
Breath Hydrogen
Time frame: 210 minutes post meal consumption
Hydrogen measured in exhale using H2 Check Analyzer
Breath Hydrogen
Time frame: 240 minutes post meal consumption
Hydrogen measured in exhale using H2 Check Analyzer
Breath Hydrogen
Time frame: 270 minutes post meal consumption
Hydrogen measured in exhale using H2 Check Analyzer
Breath Hydrogen
Time frame: 300 minutes post meal consumption
Hydrogen measured in exhale using H2 Check Analyzer
Breath Hydrogen
Time frame: 330 minutes post meal consumption
Hydrogen measured in exhale using H2 Check Analyzer
Breath Hydrogen
Time frame: 360 minutes post meal consumption
Hydrogen measured in exhale using H2 Check Analyzer
Gastrointestinal Symptoms Questionnaire
Time frame: baseline
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Gastrointestinal Symptoms Questionnaire
Time frame: 30 minutes post meal consumption
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Gastrointestinal Symptoms Questionnaire
Time frame: 60 minutes post meal consumption
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Gastrointestinal Symptoms Questionnaire
Time frame: 90 minutes post meal consumption
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Gastrointestinal Symptoms Questionnaire
Time frame: 120 minutes post meal consumption
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Gastrointestinal Symptoms Questionnaire
Time frame: 150 minutes post meal consumption
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Gastrointestinal Symptoms Questionnaire
Time frame: 180 minutes post meal consumption
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Gastrointestinal Symptoms Questionnaire
Time frame: 210 minutes post meal consumption
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Gastrointestinal Symptoms Questionnaire
Time frame: 240 minutes post meal consumption
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Gastrointestinal Symptoms Questionnaire
Time frame: 270 minutes post meal consumption
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Gastrointestinal Symptoms Questionnaire
Time frame: 300 minutes post meal consumption
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Gastrointestinal Symptoms Questionnaire
Time frame: 330 minutes post meal consumption
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Gastrointestinal Symptoms Questionnaire
Time frame: 360 minutes post meal consumption
Questionnaire that subject self-report the severity of gastrointestinal symptoms using a scale of 0 (no symptoms) to 10 (severe symptoms) for Bloating, Flatulence, Abdominal Rumblings, Abdominal Pain/Cramping, Stomach Fullness, Nausea, and Overall physical discomfort
Flatus events
Time frame: baseline
Self-reported number of flatus events each hour
Flatus events
Time frame: 60 minutes post meal consumption
Self-reported number of flatus events each hour
Flatus events
Time frame: 120 minutes post meal consumption
Self-reported number of flatus events each hour
Flatus events
Time frame: 180 minutes post meal consumption
Self-reported number of flatus events each hour
Flatus events
Time frame: 240 minutes post meal consumption
Self-reported number of flatus events each hour
Flatus events
Time frame: 300 minutes post meal consumption
Self-reported number of flatus events each hour
Flatus events
Time frame: 360 minutes post meal consumption
Self-reported number of flatus events each hour
1 secondary outcome
Concluding Questionnaire
Time frame: 60 minutes post meal consumption
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 22 Aug 2022.
- 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.
Richard Bloomer, PhD principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Charcocaps in people with Intestinal Gas, run by University of Memphis 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 8 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 22 Aug 2022. 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?
Breath Hydrogen (time frame: 0 minutes before chili meal consumed (baseline)). The study lists 33 primary outcomes in all. 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 22 Aug 2022.