GastritisA-P-REENCT00487955
The Metabolic Contribution of the Human Microbiota to Resting Energy Expenditure
An observational study of Gastritis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The purpose of our study is to evaluate the metabolic contribution of the human microbiota to resting energy expenditure Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Gastritis
- What is being tested?
- Resting Energy Expenditure examination
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2007to Dec 2007
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 40 patients that refers to helicobacter pylori treatment
- Aged 20-60 years old
- 22 Kg/m2 ≤ BMI ≤ 30 Kg/m2
- Functional GI trace with permanent stool number
- Keeping on a permanent diet
- Written informed consent
- Stated availability throughout the study period
- Mental ability to understand and follow the protocol
Who cannot join
- Use of laxatives
- Confirmed GI tract infections or inflammatory bowel disease
- Any major chronic illness
- Pregnancy
- Participation in other clinical trials
- Use of oral or intravenous antibiotics during 8 weeks prior to recruitment
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The Unit of Clinical Nutrition
Tel Aviv
Nachum Vaisman, Prof., +972-524-266-596, vaisman@tasmc.health.gov.il
Aharon Ahalak, Dr., +972-522-311-929, efratmo@tasmc.health.gov.il
About this study
The purpose of our study is to evaluate the metabolic contribution of the human microbiota to resting energy expenditure
Read the detailed description
There are now >500 million adult humans in the world who are overweight [body mass index (BMI) of 25.0-29.9 kg/m2] and 250 million who are obese (BMI 30 kg/m2). This growing epidemic threatens both industrialized and developing countries and has been accompanied by worldwide increases in obesity-related disorders, including type II diabetes, hypertension, cardiovascular pathology, and nonalcoholic fatty liver disease. In the United States, 64% of adults are overweight or obese, prompting the Surgeon General to designate this condition as the most important public health challenge of our time.
The worldwide obesity epidemic is stimulating efforts to identify host and environmental factors that affect energy balance. The Human gut contains an immense number of microorganisms, collectively known as the microbiota. This community consists of at least 1013 citizens, is dominated by anaerobic bacteria, and includes 500-1,000 species whose collective genomes are estimated to contain 100 times more genes than our own human genome. The microbiota can be viewed as a metabolic "organ" exquisitely tuned to our physiology that performs functions that we have not had to evolve on our own. These functions include the ability to process otherwise indigestible components of our diet, such as plant polysaccharides, and therefore may have an impact on our energy balance.
Comparisons of the distal gut microbiota of genetically obese mice and their lean littermates, as well as those of obese and lean human volunteers have revealed that obesity is associated with changes in the relative abundance of two dominant bacterial divisions, the Bacteroidetes and the Firmicutes. Turnbaugh et al demonstrated through metagenomic and biochemical analyses that these changes affect the metabolic potential of the mouse gut microbiota. Furthermore, this trait is transmissible: colonization of germ-free mice with an 'obese microbiota' results in a significantly greater increase in total body fat than colonization with a 'lean microbiota'. These results identify the gut microbiota as an additional contributing factor to the pathophysiology of obesity. It has been suggested, therefore, that the obese microbiome has an increased capacity to harvest energy from the diet.
- Conditions
- Gastritis
- Being tested
- Resting Energy Expenditure examination
- Keywords
- gastritis, helicobacter pylori, REE, patients with gastritis that refers to helicobacter pylori treatment
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting Energy Expenditure examinationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study startJun 2007
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Nachum Vaisman, Prof., Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487955
- Sponsor's protocol ID
- TASMC-07-AH-176-CTIL
- Acronym
- A-P-REE
- Status last verified
- Mar 2007
- First submitted
- 18 Jun 2007
- Last updated
- 19 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Contribution of the Human Microbiota to Resting Energy Expenditure
- ClinicalTrials.gov ID
- NCT00487955
- Acronym / sponsor ID
- A-P-REE / TASMC-07-AH-176-CTIL
- Conditions
- Gastritis
- Keywords
- gastritis, helicobacter pylori, REE, patients with gastritis that refers to helicobacter pylori treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jun 2007
- Study completion
- Dec 2007 (estimated)
- First posted
- 19 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of our study is to evaluate the metabolic contribution of the human microbiota to resting energy expenditure
Detailed description
There are now >500 million adult humans in the world who are overweight [body mass index (BMI) of 25.0-29.9 kg/m2] and 250 million who are obese (BMI 30 kg/m2). This growing epidemic threatens both industrialized and developing countries and has been accompanied by worldwide increases in obesity-related disorders, including type II diabetes, hypertension, cardiovascular pathology, and nonalcoholic fatty liver disease. In the United States, 64% of adults are overweight or obese, prompting the Surgeon General to designate this condition as the most important public health challenge of our time.
The worldwide obesity epidemic is stimulating efforts to identify host and environmental factors that affect energy balance. The Human gut contains an immense number of microorganisms, collectively known as the microbiota. This community consists of at least 1013 citizens, is dominated by anaerobic bacteria, and includes 500-1,000 species whose collective genomes are estimated to contain 100 times more genes than our own human genome. The microbiota can be viewed as a metabolic "organ" exquisitely tuned to our physiology that performs functions that we have not had to evolve on our own. These functions include the ability to process otherwise indigestible components of our diet, such as plant polysaccharides, and therefore may have an impact on our energy balance.
Comparisons of the distal gut microbiota of genetically obese mice and their lean littermates, as well as those of obese and lean human volunteers have revealed that obesity is associated with changes in the relative abundance of two dominant bacterial divisions, the Bacteroidetes and the Firmicutes. Turnbaugh et al demonstrated through metagenomic and biochemical analyses that these changes affect the metabolic potential of the mouse gut microbiota. Furthermore, this trait is transmissible: colonization of germ-free mice with an 'obese microbiota' results in a significantly greater increase in total body fat than colonization with a 'lean microbiota'. These results identify the gut microbiota as an additional contributing factor to the pathophysiology of obesity. It has been suggested, therefore, that the obese microbiome has an increased capacity to harvest energy from the diet.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 40 patients that refers to helicobacter pylori treatment
- Aged 20-60 years old
- 22 Kg/m2 ≤ BMI ≤ 30 Kg/m2
- Functional GI trace with permanent stool number
- Keeping on a permanent diet
Key exclusion criteria (6 listed)
- Use of laxatives
- Confirmed GI tract infections or inflammatory bowel disease
- Any major chronic illness
- Pregnancy
- Participation in other clinical trials
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 |
|---|---|---|
| Resting Energy Expenditure examination | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2007.
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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.
Nachum Vaisman, Prof. study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastritis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2007. 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 Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nachum Vaisman, Prof. (+972-524-266-596, vaisman@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 19 Jun 2007.