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| Name | Class |
|---|---|
| Weizmann Institute of Science | OTHER |
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The intestinal microbiome is a microbial system that is influenced by host genetics and environmental exposures such as nutrition, stress and medications. There is a growing body of evidence indicating the significant contribution of the gut microbiome to host health and disease. Furthermore, it has been shown that exercise may modify the microbiome composition. However, important mechanistic questions related to the possible associations between exercise and the human gut microbiome remain unanswered.
In this study, the investigators are using advanced state-of-the-art measurements of physical activity level and related metabolic parameters whether there is a connection between the microbiome and physical abilities in healthy participants and whether antibiotics consumption can influence host physical abilities and glycemic responses through changes induced in microbiome composition and function.
During all days of the study, participants will be connected to a continuous glucose monitor (CGM).
In the second segment of the study, participants will be randomized into two groups: antibiotics or placebo, which will be consumed for 7 days.
The third segment of the trial, participants will undergo an FMT/placebo administration for three consecutive days according to their randomization: participants who received antibiotics will receive FMT and participants who received placebo pills will receive placebo capsules in this segment as well.
During the study, participants will collect stool and buccal samples which will be used for microbiota profiling.
Furthermore, participants will undergo physical abilities test, anthropometric measurements, medical history questioners, blood and urine samples and Dual X-ray absorptiometry (DXA) test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotics + FMT | Experimental | 7 days of antibiotics- Ciprofloxacin, 500 mg 2/day & Metronidazole (Flagyl), 500 mg 3/day. After antibiotics administration, participants will receive 10 aFMT capsules for three consecutive days (a total of 30 capsules). |
|
| Placebo | Placebo Comparator | 7 days of cellules pills. After cellules pills administration, participants will receive 10 agarose capsules for three consecutive days (a total of 30 capsules). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotics | Drug | Ciprofloxacin, 500 mg 2/day & Metronidazole (Flagyl), 500 mg 3/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome Profiling | Collection of stool and buccal samples samples for microbiome composition analysis with16s rRNA sequencing. | 2 years |
| Body Mass Index (BMI) | The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m^2 | 2 years |
| Body Circumferences | waist, hips, and limbs (cm). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Responses | Performing continuous glucose monitor (CGM) | 2 years |
| Bone Mineral Density (BMD) | Using Dual X-ray absorptiometry (DXA) test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilan Youngster, Dr. | Contact | +972-50630119 | youngsteri@asaf.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Ilan Youngster, Dr. | Assaf-Harofeh MC, Bee'r Yaakov Israel | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25021423 | Background | Clarke SF, Murphy EF, O'Sullivan O, Lucey AJ, Humphreys M, Hogan A, Hayes P, O'Reilly M, Jeffery IB, Wood-Martin R, Kerins DM, Quigley E, Ross RP, O'Toole PW, Molloy MG, Falvey E, Shanahan F, Cotter PD. Exercise and associated dietary extremes impact on gut microbial diversity. Gut. 2014 Dec;63(12):1913-20. doi: 10.1136/gutjnl-2013-306541. Epub 2014 Jun 9. | |
| 28360096 |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D002939 | Ciprofloxacin |
| D008795 | Metronidazole |
| D000069467 | Fecal Microbiota Transplantation |
| D012685 | Sepharose |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Fecal Microbiota Transplantation | Other | Fecal Microbiota Transplantation is the process of transferring stool from a healthy donor to another. |
|
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| Cellules Pills | Other | 7 days of cellules placebo pills. |
|
| Agarose Capsules | Other | Placebo capsules consist a combination of agarose in normal saline/glycerol (the same vehicle as in a FMT capsules) |
|
| 2 years |
| Barton W, Penney NC, Cronin O, Garcia-Perez I, Molloy MG, Holmes E, Shanahan F, Cotter PD, O'Sullivan O. The microbiome of professional athletes differs from that of more sedentary subjects in composition and particularly at the functional metabolic level. Gut. 2018 Apr;67(4):625-633. doi: 10.1136/gutjnl-2016-313627. Epub 2017 Mar 30. |
| D024841 |
| Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |