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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • 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

    Recruiting

Other trials in Israel

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.

  1. First posted19 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Study completionDec 2007 (estimated)

Resources

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)
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

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.

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