ObesityPhase 2NCT02037295
Investigation of the Gut Microbiota in Regulating Nutrient Absorption in Humans
A Phase 2 study testing Vancomycin, Overfeeding diet (OF) and Underfeeding diet (UF) in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
We propose to study both stool and urine energy loss in 24 individuals on two experimental diets (50% increased and 50% reduced nutrient load relative to body size) in a random cross-over design. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Obesity
- What is being tested?
- Vancomycin, Overfeeding diet (OF) and Underfeeding diet (UF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2014to 29 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Free of acute and chronic diseases (especially GI disorders) as determined by medical history, physical examination and laboratory tests.
- Individuals may be taking laxative drugs but they must be discontinued 3 or more weeks before admission.
- Age 18-45 y (in order to minimize the affect of aging on nutrient absorption).
Who cannot join
- Because it is unclear how chronic illnesses or substance abuse could affect nutrient absorption we will exclude volunteers with chronic diseases or current substance abuse. This is especially important because the limited number of study subjects in this study will make it hard to control for these confounders. We will therefore exclude subjects with a history or clinical manifestation of:
- Current smoking
- Type 2 diabetes (according to the World Health Organization diagnostic criteria)
- Endocrine disorders, such as Cushing s disease, pituitary disorders, and hypo- and hyperthyroidism
- HIV infection (self-report), due to effects on weight and body composition of HIV and medications used to treat HIV
- Active tuberculosis (self-report)
Show all 29Show fewer
- Asthma on active daily treatment with medications
- Pulmonary disorders including physician diagnosed chronic obstructive pulmonary diseases and obstructive sleep apnea syndrome
- Cardiovascular diseases, including coronary heart disease, heart failure, arrhythmias, and peripheral artery disease
- Hypertension (according to the World Health Organization diagnostic criteria), treated or uncontrolled
- Gastrointestinal disease, including inflammatory bowel diseases (e.g. Crohn s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) and irritable bowel syndrome.
- Lactose intolerance
- Anemia (defined as hemoglobin < 11 mg/dl), leucopenia (defined as white blood cell count < 4,000/microL) or thrombocytopenia (defined as platelet count < 150,000/microL)
- Liver disease, including non-alcoholic fatty liver disease or current elevated liver enzymes over 1.5 times the normal range for AST, ALT or GGT or a history and physical exam that indicates a potential liver disease as describe by Giannini et al
- Evidence of chronic renal disease as defined by estimated glomerular filtration rate of < 60 ml/min or evidence of overt proteinuria on urine dipstick.
- Central nervous system disease, including previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders
- Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis
- Behavioral or psychiatric conditions that would be incompatible with a safe and successful participation in the study (such as major depression, schizophrenia and presence of psychotic symptoms)
- Eating disorders such as anorexia nervosa, bulimia or binge eating syndrome
- Taking weight loss drugs
- Weight change of more than 5% of total body weight in the 3 months before admission
- Use of any antibiotic or probiotic agents within 6 months prior to minimize the potential effects of these substances on the gut microbiota.
- Use of antacids (Proton pump inhibitors, H2 antagonists or aluminum/magnesium hydroxide) 3 months prior to the study assessed by self-report because a modified gastric pH might affect the gut microbiota as well
- Evidence of alcohol and/or drug abuse (more than 3 drinks per day and use of drugs, such as amphetamines, cocaine, heroin, or marijuana)
- The following exclusion criteria are necessary because of the substances given or tests performed during the study
- Known allergies to vancomycin
- Known allergies to heparin or a history of heparin-induced thrombocytopenia
- Personal history or evidence of a bleeding disorder
- All individuals will be fully informed of the aim, nature, and risks of the study prior to giving written informed consent. The study s informed consent will be obtained by a principal or associate investigator, research physician or physician assistant working in the clinical research unit.
Trial locations and contacts
1 site in 1 country.
About this study
We propose to study both stool and urine energy loss in 24 individuals on two experimental diets (50% increased and 50% reduced nutrient load relative to body size) in a random cross-over design. Following this over/underfeeding, volunteers will also be randomly assigned to a placebo versus oral antibiotic medication arm. This study will extend our previous findings by investigating whether 1) nutrient absorption changes upon similar increases/decreases in relative nutrient load and 2) whether manipulation of gut microbial communities with antibiotics alters nutrient absorption and 3) how these changes may affect glucose tolerance and fat storage.
Read the detailed description
The prevalence of obesity has risen to epidemic proportions in the world, resulting from both excessive energy intake and low levels of energy expenditure. The effect of nutrient absorption on energy balance, that is, the relative amount of nutrients consumed vs. the amount excreted in stool, has been reported only in small studies in which energy waste in feces and urine between lean and obese individuals was not found to be different. New studies have shown that bacteria in the gut may play an important role in calorie absorption. We have recently shown that leaner individuals absorbed more calories when overfed compared to when they were given a diet with just enough calories to maintain their own weight. Our studies have also found that overfeeding also changes the kinds of bacteria found in the gut. In lean individuals, these changes in gut bacterial communities with overfeeding were associated with changes in how many calories were absorbed. Our results are similar to those seen in other studies in animals and humans that suggest a role for gut bacteria in weight gain and obesity. To try to better understand the role of gut bacteria in absorbing food, we propose to investigate 1) whether energy loss (as measured in stool and urine) changes following over- and underfeeding relative to body size and 2) whether changes in the gut bacteria, induced by an antibiotic medication, affect nutrient absorption and glucose tolerance. We plan to study 24 healthy non-smoking volunteers age 18 45 years old, not taking any medications (including medications for weight loss, antibiotics or probiotics) for the examination. All participants will be admitted to the Clinical Research Unit for 31 days. During their stay, subjects will be fed a weight maintaining diet for 3 days, followed by two experimental diets (150% and 50% of weight maintaining calories) in a random order. After this, volunteers will be randomly assigned to one of two groups: group 1 will take oral antibiotic medication; group 2 will receive pills that look the same but will not contain any active medication (placebos). Feces (stool) will be collected throughout the study. Additionally, twenty four-hour urine collections will take place each day of the experimental diet period and when stool is collected on the antibiotics. The energy content of these waste products as well as that of the diet (using duplicate plate analysis) will be measured by bomb calorimetry. Bacterial components in feces will be extracted by repeated fractional centrifugation to obtain bacterial mass and by using 16S rDNA-based oligonucleotide probes to obtain data on gut bacteria. Primary results will examine how many calories remain in stool during relative over- and underfeeding and whether changes in gut bacteria, induced by an antibiotic medication, affect nutrient absorption and glucose tolerance.
- Conditions
- Obesity
- Being tested
- Vancomycin, Placebo oral tablet, Overfeeding diet (OF), Underfeeding diet (UF)
- Keywords
- Gut Microbiota, Obesity, Absorption, Overfeeding
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Vancomycin 125mg orally four times per day for 12 days
Placebo oral tabletDrug
Placebo pills orally four times per day for 12 days
Overfeeding diet (OF)Other
Diet in which the calories are 150% of their weight maintaining energy requirements
Underfeeding diet (UF)Other
Diet in which the calories are 50% of their weight maintaining energy requirements
| Study group | Role | What they receive |
|---|---|---|
| OF_UF Vancomycin | Experimental | Healthy volunteers assigned overfeeding diet, underfeeding diet, and then vancomycin Receives: Drug: Vancomycin; Other: Overfeeding diet (OF); Other: Underfeeding diet (UF) |
| OF_UF Placebo | Placebo comparator | Healthy volunteers assigned overfeeding diet, underfeeding diet, and then placebo Receives: Drug: Placebo oral tablet; Other: Overfeeding diet (OF); Other: Underfeeding diet (UF) |
| UF_OF Vancomycin | Experimental | Healthy volunteers assigned underfeeding diet, overfeeding diet, and then vancomycin Receives: Drug: Vancomycin; Other: Overfeeding diet (OF); Other: Underfeeding diet (UF) |
| UF_OF Placebo | Placebo comparator | Healthy volunteers assigned underfeeding diet, overfeeding diet, and then placebo Receives: Drug: Placebo oral tablet; Other: Overfeeding diet (OF); Other: Underfeeding diet (UF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool Calories During OF and UF
Calculated as stool calories (kcal/day) x 100/ingested calories (kcal/day)
Measured: Days 5-7 and 11-13
Stool Calories During Vancomycin and Placebo
Calculated as stool calories (kcal/day) x 100/ingested calories (kcal/day), vancomycin compared to placebo
Measured: Days 23-25
Secondary outcomes (5)
Urine Calories During OF and UF
Calculated as urine calories (kcal/day) x 100/ingested calories (kcal/day)
Measured: Days 5-7 and 11-13
Urine Calories During Vancomycin and Placebo
Calculated as urine calories (kcal/day) x 100/ingested calories (kcal/day), vancomycin compared to placebo
Measured: Days 23-25
Change in 2 Hour Glucose Tolerance From Day 16 to Day 28 During Vancomycin and Placebo
A 75-g 2 hour oral glucose tolerance test (OGTT) was performed on days 16 and 28, before and after treatment with vancomycin or placebo.
Measured: Day 16 and day 28
Overall Gut Microbial Colonization During OF and UF
qPCR-based quantification of 16S rRNA gene copies per gram wet weight (log10)
Measured: Days 5-7 and 11-13
Overall Gut Microbial Colonization During Vancomycin and Placebo
qPCR-based quantification of 16S rRNA gene copies per gram wet weight (log10)
Measured: Days 23-25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study start14 Jan 2014
- Primary completion29 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jonathan Krakoff, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037295
- Sponsor's protocol ID
- 999914045
- Other IDs
- 14-DK-N045
- Status last verified
- 29 Mar 2019
- First submitted
- 14 Jan 2014
- Last updated
- 31 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Yanovski SZ, Yanovski JA. Obesity. N Engl J Med. 2002 Feb 21;346(8):591-602. doi: 10.1056/NEJMra012586. No abstract available.
PubMed 11856799Weststrate JA, Dekker J, Stoel M, Begheijn L, Deurenberg P, Hautvast JG. Resting energy expenditure in women: impact of obesity and body-fat distribution. Metabolism. 1990 Jan;39(1):11-7. doi: 10.1016/0026-0495(90)90141-x.
PubMed 2294371Segal KR, Dunaif A. Resting metabolic rate and postprandial thermogenesis in polycystic ovarian syndrome. Int J Obes. 1990 Jul;14(7):559-67.
PubMed 2228390Basolo A, Hohenadel M, Ang QY, Piaggi P, Heinitz S, Walter M, Walter P, Parrington S, Trinidad DD, von Schwartzenberg RJ, Turnbaugh PJ, Krakoff J. Effects of underfeeding and oral vancomycin on gut microbiome and nutrient absorption in humans. Nat Med. 2020 Apr;26(4):589-598. doi: 10.1038/s41591-020-0801-z. Epub 2020 Mar 23.
PubMed 32235930Basolo A, Parrington S, Ando T, Hollstein T, Piaggi P, Krakoff J. Procedures for Measuring Excreted and Ingested Calories to Assess Nutrient Absorption Using Bomb Calorimetry. Obesity (Silver Spring). 2020 Dec;28(12):2315-2322. doi: 10.1002/oby.22965. Epub 2020 Oct 7.
PubMed 33029899
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Gut Microbiota in Regulating Nutrient Absorption in Humans
- ClinicalTrials.gov ID
- NCT02037295
- Acronym / sponsor ID
- 999914045
- Conditions
- Obesity
- Keywords
- Gut Microbiota, Obesity, Absorption, Overfeeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 14 Jan 2014
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Posted 31 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to study both stool and urine energy loss in 24 individuals on two experimental diets (50% increased and 50% reduced nutrient load relative to body size) in a random cross-over design. Following this over/underfeeding, volunteers will also be randomly assigned to a placebo versus oral antibiotic medication arm. This study will extend our previous findings by investigating whether 1) nutrient absorption changes upon similar increases/decreases in relative nutrient load and 2) whether manipulation of gut microbial communities with antibiotics alters nutrient absorption and 3) how these changes may affect glucose tolerance and fat storage.
Detailed description
The prevalence of obesity has risen to epidemic proportions in the world, resulting from both excessive energy intake and low levels of energy expenditure. The effect of nutrient absorption on energy balance, that is, the relative amount of nutrients consumed vs. the amount excreted in stool, has been reported only in small studies in which energy waste in feces and urine between lean and obese individuals was not found to be different. New studies have shown that bacteria in the gut may play an important role in calorie absorption. We have recently shown that leaner individuals absorbed more calories when overfed compared to when they were given a diet with just enough calories to maintain their own weight. Our studies have also found that overfeeding also changes the kinds of bacteria found in the gut. In lean individuals, these changes in gut bacterial communities with overfeeding were associated with changes in how many calories were absorbed. Our results are similar to those seen in other studies in animals and humans that suggest a role for gut bacteria in weight gain and obesity. To try to better understand the role of gut bacteria in absorbing food, we propose to investigate 1) whether energy loss (as measured in stool and urine) changes following over- and underfeeding relative to body size and 2) whether changes in the gut bacteria, induced by an antibiotic medication, affect nutrient absorption and glucose tolerance. We plan to study 24 healthy non-smoking volunteers age 18 45 years old, not taking any medications (including medications for weight loss, antibiotics or probiotics) for the examination. All participants will be admitted to the Clinical Research Unit for 31 days. During their stay, subjects will be fed a weight maintaining diet for 3 days, followed by two experimental diets (150% and 50% of weight maintaining calories) in a random order. After this, volunteers will be randomly assigned to one of two groups: group 1 will take oral antibiotic medication; group 2 will receive pills that look the same but will not contain any active medication (placebos). Feces (stool) will be collected throughout the study. Additionally, twenty four-hour urine collections will take place each day of the experimental diet period and when stool is collected on the antibiotics. The energy content of these waste products as well as that of the diet (using duplicate plate analysis) will be measured by bomb calorimetry. Bacterial components in feces will be extracted by repeated fractional centrifugation to obtain bacterial mass and by using 16S rDNA-based oligonucleotide probes to obtain data on gut bacteria. Primary results will examine how many calories remain in stool during relative over- and underfeeding and whether changes in gut bacteria, induced by an antibiotic medication, affect nutrient absorption and glucose tolerance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OF_UF Vancomycin | Experimental | Drug: Vancomycin, Other: Overfeeding diet (OF), Other: Underfeeding diet (UF)Healthy volunteers assigned overfeeding diet, underfeeding diet, and then vancomycin |
| OF_UF Placebo | Placebo comparator | Drug: Placebo oral tablet, Other: Overfeeding diet (OF), Other: Underfeeding diet (UF)Healthy volunteers assigned overfeeding diet, underfeeding diet, and then placebo |
| UF_OF Vancomycin | Experimental | Drug: Vancomycin, Other: Overfeeding diet (OF), Other: Underfeeding diet (UF)Healthy volunteers assigned underfeeding diet, overfeeding diet, and then vancomycin |
| UF_OF Placebo | Placebo comparator | Drug: Placebo oral tablet, Other: Overfeeding diet (OF), Other: Underfeeding diet (UF)Healthy volunteers assigned underfeeding diet, overfeeding diet, and then placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Free of acute and chronic diseases (especially GI disorders) as determined by medical history, physical examination and laboratory tests.
- Individuals may be taking laxative drugs but they must be discontinued 3 or more weeks before admission.
- Age 18-45 y (in order to minimize the affect of aging on nutrient absorption).
Key exclusion criteria (29 listed)
- Because it is unclear how chronic illnesses or substance abuse could affect nutrient absorption we will exclude volunteers with chronic diseases or current substance abuse. This is especially important because the limited number of study subjects in this study will make it hard to control for these confounders. We will therefore exclude subjects with a history or clinical manifestation of:
- Current smoking
- Type 2 diabetes (according to the World Health Organization diagnostic criteria)
- Endocrine disorders, such as Cushing s disease, pituitary disorders, and hypo- and hyperthyroidism
- HIV infection (self-report), due to effects on weight and body composition of HIV and medications used to treat HIV
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 |
|---|---|---|
| VancomycinVancomycin 125mg orally four times per day for 12 days | Drug | OF_UF Vancomycin, UF_OF Vancomycin |
| Placebo oral tabletPlacebo pills orally four times per day for 12 days | Drug | OF_UF Placebo, UF_OF Placebo |
| Overfeeding diet (OF)Diet in which the calories are 150% of their weight maintaining energy requirements | Other | OF_UF Placebo, OF_UF Vancomycin, UF_OF Placebo, UF_OF Vancomycin |
| Underfeeding diet (UF)Diet in which the calories are 50% of their weight maintaining energy requirements | Other | OF_UF Placebo, OF_UF Vancomycin, UF_OF Placebo, UF_OF Vancomycin |
Primary outcome
Stool Calories During OF and UF
Time frame: Days 5-7 and 11-13
Calculated as stool calories (kcal/day) x 100/ingested calories (kcal/day)
Stool Calories During Vancomycin and Placebo
Time frame: Days 23-25
Calculated as stool calories (kcal/day) x 100/ingested calories (kcal/day), vancomycin compared to placebo
5 secondary outcomes
Urine Calories During OF and UF
Time frame: Days 5-7 and 11-13
Urine Calories During Vancomycin and Placebo
Time frame: Days 23-25
Change in 2 Hour Glucose Tolerance From Day 16 to Day 28 During Vancomycin and Placebo
Time frame: Day 16 and day 28
Overall Gut Microbial Colonization During OF and UF
Time frame: Days 5-7 and 11-13
Overall Gut Microbial Colonization During Vancomycin and Placebo
Time frame: Days 23-25
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11856799Yanovski SZ, Yanovski JA. Obesity. N Engl J Med. 2002 Feb 21;346(8):591-602. doi: 10.1056/NEJMra012586. No abstract available.
- Background: PubMed 2294371Weststrate JA, Dekker J, Stoel M, Begheijn L, Deurenberg P, Hautvast JG. Resting energy expenditure in women: impact of obesity and body-fat distribution. Metabolism. 1990 Jan;39(1):11-7. doi: 10.1016/0026-0495(90)90141-x.
- Background: PubMed 2228390Segal KR, Dunaif A. Resting metabolic rate and postprandial thermogenesis in polycystic ovarian syndrome. Int J Obes. 1990 Jul;14(7):559-67.
- Results publication: PubMed 32235930Basolo A, Hohenadel M, Ang QY, Piaggi P, Heinitz S, Walter M, Walter P, Parrington S, Trinidad DD, von Schwartzenberg RJ, Turnbaugh PJ, Krakoff J. Effects of underfeeding and oral vancomycin on gut microbiome and nutrient absorption in humans. Nat Med. 2020 Apr;26(4):589-598. doi: 10.1038/s41591-020-0801-z. Epub 2020 Mar 23.
- Derived from this study: PubMed 33029899Basolo A, Parrington S, Ando T, Hollstein T, Piaggi P, Krakoff J. Procedures for Measuring Excreted and Ingested Calories to Assess Nutrient Absorption Using Bomb Calorimetry. Obesity (Silver Spring). 2020 Dec;28(12):2315-2322. doi: 10.1002/oby.22965. Epub 2020 Oct 7.
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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.
Jonathan Krakoff, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vancomycin, Overfeeding diet (OF) and Underfeeding diet (UF) in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 3 inclusion and 29 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 31 Jul 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Stool Calories During OF and UF (time frame: Days 5-7 and 11-13). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02037295, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.