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Complex oligosaccharides can alter the gut microbiome by aiding in the growth of certain organisms, and possibly, inhibiting others. The synergy with a probiotic may enhance gastrointestinal colonization.
The study will evaluate the synergy of the use of a complex oligosaccharide with and without a probiotic on the human microbiome in healthy volunteers who have received antibiotics. The combination should support general gastrointestinal health.
This study is a multi-dose randomized cohort trial using 18 subjects per cohort for a total of 90 healthy adult volunteers ages 18-75.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | D1-D5: Antibiotics (3x daily) |
| |
| Arm 2 | D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 18 g HMO concentrate (9g twice daily) |
| |
| Arm 3 | D1-D5: Antibiotics (3x daily) D1-D14: Probiotic |
| |
| Arm 4 | D1-D5: Antibiotics (3x daily) D1-D14: Probiotic + 18 g HMO concentrate (9g twice daily) D15-D28: 22g Food Supplement (11 g daily) |
| |
| Arm 5 | D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 22g Food Supplement (11 g daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic | Dietary Supplement | Vancomycin (250 mg/dose), Metronidazole (500 mg/dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Evaluation of HMO supporting gut colonization of B.infantis in healthy adult volunteers with microbiome disruption by antibiotics. Stool samples were taken from subjects at regular intervals and prepared for DNA extraction and microbiome analysis. Following DNA extraction, samples were analyzed using subspecies-specific qPCR analysis to evaluate B.infantis colonization and monitor overall shifts using primers that target universal 16S rRNA gene shared by bacteria by log-fold changes. | Baseline, Day, 5, 14, 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Immune Markers Assessment at Day 5, 14 and 28 | Blood samples were collected at regular intervals for serum immunological parameters (LAP-TGFB, MCP1, MIP-1) to assess metabolite levels. | Baseline-28 days |
| Blood Pressures of Subjects From Baseline to Day 35 |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy Adults, ages 18-75.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences | Cypress | California | 90630 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Antibiotics Alone | Antibiotics (Only) |
| FG001 | Antibiotics, Probiotic, HMO | Antibiotics, Probiotic, HMO Concentrate |
| FG002 | Antibiotics Probiotic | Antibiotics, Probiotic |
| FG003 | Antibiotics, Probiotic, HMO, Food | Antibiotics, Probiotic, HMO concentrate, Food Supplement |
| FG004 | Antibiotics, Probiotic, Food | Antibiotics, Probiotic, Food Supplement |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Antibiotics Alone | D1-D5: Antibiotics (3x daily) Antibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose) |
| BG001 | Antibiotics, Probiotic, HMO | D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 18 g HMO concentrate (9g twice daily) Antibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose) HMO Concentrate: Concentrated milk fortifiers from donor human milk Probiotic: B. infantis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Evaluation of HMO supporting gut colonization of B.infantis in healthy adult volunteers with microbiome disruption by antibiotics. Stool samples were taken from subjects at regular intervals and prepared for DNA extraction and microbiome analysis. Following DNA extraction, samples were analyzed using subspecies-specific qPCR analysis to evaluate B.infantis colonization and monitor overall shifts using primers that target universal 16S rRNA gene shared by bacteria by log-fold changes. | All participants assigned to an arm and were able to provide adequate evaluable samples for DNA analysis | Posted | Geometric Mean | Standard Deviation | copies/ng DNA | Baseline, Day, 5, 14, 35 |
|
up to 7 weeks (D1 through D35)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Antibiotics (Only) | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Rechtman VP, Medical Affairs | Prolacta Bioscience | 8887765228 | drechtman@prolacta.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 22, 2022 | Mar 14, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2023 | Mar 14, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D019936 | Probiotics |
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Serum, Urine, and Stool
| HMO Concentrate | Dietary Supplement | Concentrated milk fortifiers from donor human milk |
|
| Probiotic | Dietary Supplement | B. infantis |
|
| Food Supplement | Dietary Supplement | Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT) |
|
Clinical assessments from baseline throughout study to assess vital signs of subject safety (blood pressure [BP]). Descriptive statistics performed by dose group and visit. |
| Day 0 - 35 |
| Heart Rates of Subjects From Baseline to Day 35 | Clinical assessment from baseline throughout study to assess vital signs of subject safety (heart rate). Descriptive statistics performed by dose group and visit. | Day 0-35 |
| Respiratory Rates of Subjects From Baseline to Day 35 | Clinical assessment from baseline throughout study to assess vital signs of subject safety (respiratory rate). Descriptive statistics performed by dose group and visit. | Day 0-35 |
| Temperatures of Subjects From Baseline to Day 35 | Clinical assessment from baseline throughout study to assess vital signs of subject safety (temperature). | Day 0-35 |
| Other |
|
| BG002 | Antibiotics, Probiotic | D1-D5: Antibiotics (3x daily) D1-D14: Probiotic Antibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose) Probiotic: B. infantis |
| BG003 | Antibiotics, Probiotic, HMO, Food | D1-D5: Antibiotics (3x daily) D1-D14: Probiotic + 18 g HMO concentrate (9g twice daily) D15-D28: 22g Food Supplement (11 g daily) Antibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose) HMO Concentrate: Concentrated milk fortifiers from donor human milk Probiotic: B. infantis Food Supplement: Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT) |
| BG004 | Antibiotics, Probiotic, Food | D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 22g Food Supplement (11 g daily) Antibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose) Probiotic: B. infantis Food Supplement: Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT) |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Levels of B. Infantis | Mean | Standard Deviation | copies/ng DNA |
|
| OG001 | Antibiotics, Probiotics, HMO | Antibiotics, Probiotic, HMO Concentrate |
| OG002 | Antibiotics Probiotics | Antibiotics and Probiotic |
| OG003 | Antibiotics, Probiotics, HMO, Food | Antibiotics, Probiotic, HMO concentrate, Food Supplement |
| OG004 | Antibiotics, Probiotics, Food | Antibiotics, Probiotic, Food Supplement |
|
|
|
| Secondary | Changes in Immune Markers Assessment at Day 5, 14 and 28 | Blood samples were collected at regular intervals for serum immunological parameters (LAP-TGFB, MCP1, MIP-1) to assess metabolite levels. | Analysis of Group 1 control vs Group 2 +HMO to assess impact of study product. Subjects who provided evaluable samples for all time points were evaluated for clinical pharmacology endpoints. DATA WERE COLLECTED FOR ONLY GROUPS 1 AND 2. | Posted | Mean | Standard Deviation | ng/mL | Baseline-28 days |
|
|
|
| Secondary | Blood Pressures of Subjects From Baseline to Day 35 | Clinical assessments from baseline throughout study to assess vital signs of subject safety (blood pressure [BP]). Descriptive statistics performed by dose group and visit. | All participants assigned to an arm and were able to provide blood pressure data. | Posted | Mean | Standard Deviation | mmHg | Day 0 - 35 |
|
|
|
| Secondary | Heart Rates of Subjects From Baseline to Day 35 | Clinical assessment from baseline throughout study to assess vital signs of subject safety (heart rate). Descriptive statistics performed by dose group and visit. | All participants assigned to an arm and were able to provide heart rate data. | Posted | Mean | Standard Deviation | beats per minute | Day 0-35 |
|
|
|
| Secondary | Respiratory Rates of Subjects From Baseline to Day 35 | Clinical assessment from baseline throughout study to assess vital signs of subject safety (respiratory rate). Descriptive statistics performed by dose group and visit. | All participants assigned to an arm and were able to provide respiration rates | Posted | Mean | Standard Deviation | breaths per minute | Day 0-35 |
|
|
|
| Secondary | Temperatures of Subjects From Baseline to Day 35 | Clinical assessment from baseline throughout study to assess vital signs of subject safety (temperature). | All participants assigned to an arm and were able to provide temperatures. | Posted | Mean | Standard Deviation | deg C | Day 0-35 |
|
|
|
| 19 |
| 0 |
| 19 |
| 4 |
| 19 |
| EG001 | Arm 2 | Antibiotics, Probiotic, HMO Concentrate | 0 | 19 | 0 | 19 | 4 | 19 |
| EG002 | Arm 3 | Antibiotics, Probiotic | 0 | 18 | 0 | 18 | 6 | 18 |
| EG003 | Arm 4 | Antibiotics, Probiotic, HMO concentrate, Food Supplement | 0 | 18 | 0 | 18 | 7 | 18 |
| EG004 | Arm 5 | Antibiotics, Probiotic, Food Supplement | 0 | 18 | 0 | 18 | 2 | 18 |
| Abdominal Distension | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| GI Hypermotility | Gastrointestinal disorders | Systematic Assessment |
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| Dry Lips | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| SARS-COV-2 Test Positive | Investigations | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D005502 |
| Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| LAP-TGFB - Day 14 |
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| LAP-TGFB - Day 28 |
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| MCP1 - Baseline |
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| MCP1 - Day 5 |
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| MCP1 - Day 14 |
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| MCP1 - Day 28 |
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| MIP - Baseline |
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| MIP - Day 5 |
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| MIP - Day 14 |
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| MIP - Day 28 |
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| Systolic Blood Pressure (mmHg) - Day 35 |
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| Diastolic Blood Pressure (mmHg) - Baseline |
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| Diastolic Blood Pressure (mmHg) - Day 35 |
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| Heart rate - Day 35 |
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| Respirations - Day 35 |
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| Temperature - Day 35 |
|