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| Name | Class |
|---|---|
| Pendulum Therapeutics | INDUSTRY |
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This study plans to evaluate the effect of consuming a symbiotic (probiotic + prebiotic) for 3 months on body weight, body composition, glucose sensitivity, and psychological parameters, as well as on gut and blood microbial composition. Synbiotic consumption is preceded by a 3-day antibiotic course to help ensure the opening of new niches (houses) for the upcoming beneficial bacteria.
This is a triple-blinded, randomized clinical trial in which participants will be allocated to one of two groups: 1) 3-day antibiotic followed by synbiotic consumption for 3 months or 2) 3-day antibiotic followed by placebo consumption for 3 months.
Blood and stool samples will be collected before the antibiotic, and before and after the symbiotic intervention in both groups.
Gut microbial composition will be analyzed through whole genome sequencing and blood microbial composition through 16S rRNA.
Glucose sensitivity will be measured through fasting glucose, fasting insulin, and HbA1c.
Body composition through DXA and BodPod will be measured before and after the symbiotic intervention.
Psychological questionnaires such as the Beck Anxiety and the Beck Depression Inventories, as well as the RED-9 questionnaire to respectively measure anxiety, depression, and food cravings, will be applied before and after the symbiotic intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synbiotic Group | Experimental | They will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month symbiotic. The synbiotic that will be used in this trial contains the oligosaccharide-degrading probiotics, Akkermansia muciniphila and Bifidobacterium infantis; butyrate producers such as Clostridium beijerinckii, Anaerobutyricum hallii, and Clostridium butyricum; and chicory-derived inulin, a prebiotic dietary fiber. |
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| Placebo Group | Placebo Comparator | They will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synbiotic Group | Dietary Supplement | WBF-038: Noninfectious and nonhazardous lyophilized commensal bacteria (probiotics). Contains no genetically modified organisms (GMOs) and contains no animal ingredients or by-products, and were originally isolated from human sources. The (probiotic) strains are grown in a FDA registered food facility, adhering to Good Manufacturing Practice (GMP) conditions. Probiotic Ingredients: Clostridium butyricum WBSTR-0006, Clostridium beijerinckii WB-STR-0005, Anaerobutyricum hallii WB-STR-0008, Akkermansia muciniphila WBSTR-0001, and Bifidobacterium infantis The product also contains: Chicory inulin and oligofructose (prebiotic fiber), hypromellose (vegetarian capsule), fruit & vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Body Fat Mass through DXA (percentage) | We will measure body fat mass by using DXA analysis. | These analyses will take place right before and right after the 3-month synbiotic/placebo intervention. |
| Total Body Fat Mass through BodPod (percentage) | We will measure body fat mass by using BodPod analysis. | These analyses will take place right before and right after the 3-month synbiotic/placebo intervention. |
| Fat Mass to Height (kg/m2) | We will measure body fat mass by using DXA analysis. | These analyses will take place right before and right after the 3-month synbiotic/placebo intervention. |
| Fat Mass (kg) | We will measure body fat mass by using BodPod analysis. | These analyses will take place right before and right after the 3-month synbiotic/placebo intervention. |
| Body Lean Mass to Height (kg/m2) | We will measure body lean mass by using DXA analysis. | These analyses will take place right before and right after the 3-month synbiotic/placebo intervention. |
| Fat Free Mass (%) | We will measure body lean mass by using BodPod analysis. | These analyses will take place right before and right after the 3-month synbiotic/placebo intervention. |
| Fat Free Mass (Kg) | We will measure body lean mass by using BodPod analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisa Marroquin, Ph.D. | Contact | 817-257-1031 | E.Marroquin@tcu.edu | |
| Ryan Porter, Ph.D. | Contact | 817-257-6868 | r.porter@tcu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elisa Marroquin, Ph.D. | Texas Christian University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31263284 | Background | Depommier C, Everard A, Druart C, Plovier H, Van Hul M, Vieira-Silva S, Falony G, Raes J, Maiter D, Delzenne NM, de Barsy M, Loumaye A, Hermans MP, Thissen JP, de Vos WM, Cani PD. Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study. Nat Med. 2019 Jul;25(7):1096-1103. doi: 10.1038/s41591-019-0495-2. Epub 2019 Jul 1. | |
| 32675291 |
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De-identified participant-level data can be shared only after authors and co-authors have published the material of their interest.
Data will be available only after authors and co-authors have published the material of their interest.
Not available at this point. Recruitment has not started.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2023 | Jan 9, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 19, 2023 | Dec 20, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Sixty participants will be randomized into one of two groups: 1) 3-day antibiotic plus placebo for 3 months, or 2) 3-day antibiotic plus symbiotic for 3 months.
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This is a triple-blind study. Participants, the research staff, the PI, and the biostatistician will be all blinded. A university staff person who does not belong to the research team or the funding agency but has been CITI certified and approved by the IRB will hold the key of the assignment key.
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| Placebo Group | Other | Ingredients: Chicory inulin and oligofructose (prebiotic fiber, hypromellose (vegetarian capsule), fruit & vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation). |
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| These analyses will take place right before and right after the 3-month synbiotic/placebo intervention. |
| Visceral Fat Volume (cm3) | We will measure body visceral mass by using DXA and BodPod analysis. | These analyses will take place right before and right after the 3-month synbiotic/placebo intervention. |
| Visceral Fat Mass (grams) | We will measure body visceral mass by using DXA and BodPod analysis. | These analyses will take place right before and right after the 3-month synbiotic/placebo intervention. |
| Fasting Glucose (mg/dL) | We will measure fasting glucose after a 12h fast. | Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention. |
| Fasting Insulin (mIU/L) | We will measure fasting insulin after a 12h fast. | Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention. |
| HbA1c (%) | We will measure HbA1c after a 12h fast. | Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention. |
| Anxiety (number in 0-63 scale) | We will measure anxiety by using the Beck Anxiety inventory. The higher the number, the higher the anxiety levels. | These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention. |
| Depression (number in 0-63 scale) | We will measure depression by using the Beck Depression inventory. The higher the number, the higher the depression. | These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention. |
| Food cravings (number in 0-52 scale) | We will measure food cravings by using the Reward-based Eating Drive questionnaire (RED-9). The higher the number, the higher the cravings. | These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention. |
| Gut Microbial Composition (depending on funding availability at the time of analysis) | We plan to measure gut microbial composition by performing whole metagenome sequencing previously stored in Zymo stool collection tubes. | Stool samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention. |
| Blood Microbial Composition (depending on funding availability at the time of analysis) | We plan to measure blood microbial composition by performing 16S rRNA in blood samples previously stored in Zymo blood collection tubes. | Blood samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention. |
| Body Weight (kg) | Body weight will be measured with a calibrated scale. | Measurements will take place at each of the 3 visits: right before the antibiotic, right before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention. |
| Body Height (meters) | Body height will be measured with a stadiometer. | Measurement will take place at the first visit. |
| Background |
| Perraudeau F, McMurdie P, Bullard J, Cheng A, Cutcliffe C, Deo A, Eid J, Gines J, Iyer M, Justice N, Loo WT, Nemchek M, Schicklberger M, Souza M, Stoneburner B, Tyagi S, Kolterman O. Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001319. doi: 10.1136/bmjdrc-2020-001319. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |