RECRUITING

Synbiotic to Attenuate Resorption of the Skeleton

Conditions

Osteoporosis Inflammation Aging Dietary probiotics Dietary prebiotics Gut microbiome Older women Randomized Controlled Trial

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This randomized, double blind, placebo controlled clinical trial will test the efficacy of a probiotic/prebiotic combination ("synbiotic") on the skeleton in older women.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Clinical Food Trial of Probiotic/Prebiotic Medical Food for the Dietary Management of Age Related Bone Loss

Quick Facts

Study Start:2024-08-12

Study Completion:2028-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06389539

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Provide written informed consent 2. Stated availability throughout entire study period and willingness to fulfill all details of the protocol 3. Age 60 years and above 4. DXA-BMD of the hip and spine (T-score) \> -2.5. Women with a BMD T score ≤ -2.5 (i.e. women with low BMD indicating osteoporosis) will also be considered if they have decided not to accept the standard of care with use of osteoporosis medications for the entire duration of their participation in the study. 5. 25-hydroxy vitamin D ≥ 20 ng/mL 6. Normal renal function (eGFR \>50 ml/min) 7. Have chosen to not accept the standard of care with use of osteoporosis medications for the duration of the study. 8. Willing to comply with protocol and report on compliance and side effects during study period.	1. BMI greater than equal to 35 kg/m2. 2. Participants consuming dietary supplements (fish oil, probiotics/prebiotics, and fiber) in the prior month, and and unwilling to avoid these supplements for the duration of the study. 3. Known or suspected allergies to probiotics, gelatin, rice, edible fruit extract or berries. 4. We will exclude women using antibiotics in the past 3 months but those placed on an antibiotic after enrollment, will be retained. 5. History of drug and/or alcohol abuse at the time of enrolment. 6. Presence of any of the following: 1. History of other bone disorders (e.g. Paget's disease) 2. History of major low-trauma fragility fractures (hip, forearm, humerus, spine) since the age of 50 years 3. History of cancer other than skin cancer \<5 years in remission, autoimmune disease, immune problems such as AIDS, type 1 or 2 diabetes, gastrointestinal disorders (ulcerative colitis, inflammatory bowel disease) 4. History of colon resection, any disease that could interfere with the intestinal barrier function such as ulcerative colitis, irritable bowel syndrome or Crohn's disease 5. Women with untreated hyperparathyroidism 6. History of chronic antibiotic use 7. History of bariatric surgery 8. History of partial colectomy 9. History of problems with pancreas 10. History of history of chronic Hepatitis B or Hepatitis C, cirrhosis, fatty liver (nonalcoholic steatohepatitis; NASH) or chronic liver disease 11. History of problems with your heart valves, endocarditis, or previously had a valve replacement 12. Currently have problems with bone marrow such as myelodysplastic syndrome or anemia requiring transfusions 13. Women with spine abnormalities that would interfere with the assessment of BMD 14. Current smoking or use of nicotine products within the past 6-months 15. Major surgery or endoscopy within last 3 months 16. Coloscopy planned in the next 18-months and unwilling to reschedule it 17. Indwelling catheter, implanted hardware/prosthetic device or feeding tube 18. Any medical condition that could interfere with the conduct of the study 7. Treatment with calcitonin, estrogens, selective estrogen receptor modulators, progestins, anabolic steroids, or glucocorticoids in the past 6 months 8. Treatment with bisphosphonates in the past 3 yrs 9. Previous treatment with parathyroid hormone (PTH), abaloparatide, romosozumab or denosumab in the last year or current coumadin use. 10. Participation in other bone, diet, autoimmune, or GI related clinical trials in the last 6 months. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study. 11. Participants who plan on changing diet and/or exercise regime during trial participation. 12. Screening laboratory tests greater than upper normal limit (ULN) or less than lower normal limit (LLN): * 25-hydroxy vitamin D \<20 ng/mL * Renal dysfunction (eGFR ≤50 ml/min) 13. Seated blood pressure greater than equal to 160 mm Hg or seated diastolic BP greater than equal to 100mm Hg. 14. Short Blessed Test score \>10 or judged by the research staff as unable to follow the study protocol 15. Current treatment or previous with Glucagon-like peptide (GLP-1) agonists in the last one year. 16. Any other condition that in the opinion of the investigator or study clinician would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study.

Inclusion Criteria

Exclusion Criteria

1. Provide written informed consent
2. Stated availability throughout entire study period and willingness to fulfill all details of the protocol
3. Age 60 years and above
4. DXA-BMD of the hip and spine (T-score) \> -2.5. Women with a BMD T score ≤ -2.5 (i.e. women with low BMD indicating osteoporosis) will also be considered if they have decided not to accept the standard of care with use of osteoporosis medications for the entire duration of their participation in the study.
5. 25-hydroxy vitamin D ≥ 20 ng/mL
6. Normal renal function (eGFR \>50 ml/min)
7. Have chosen to not accept the standard of care with use of osteoporosis medications for the duration of the study.
8. Willing to comply with protocol and report on compliance and side effects during study period.

1. BMI greater than equal to 35 kg/m2.
2. Participants consuming dietary supplements (fish oil, probiotics/prebiotics, and fiber) in the prior month, and and unwilling to avoid these supplements for the duration of the study.
3. Known or suspected allergies to probiotics, gelatin, rice, edible fruit extract or berries.
4. We will exclude women using antibiotics in the past 3 months but those placed on an antibiotic after enrollment, will be retained.
5. History of drug and/or alcohol abuse at the time of enrolment.
6. Presence of any of the following:
1. History of other bone disorders (e.g. Paget's disease)
2. History of major low-trauma fragility fractures (hip, forearm, humerus, spine) since the age of 50 years
3. History of cancer other than skin cancer \<5 years in remission, autoimmune disease, immune problems such as AIDS, type 1 or 2 diabetes, gastrointestinal disorders (ulcerative colitis, inflammatory bowel disease)
4. History of colon resection, any disease that could interfere with the intestinal barrier function such as ulcerative colitis, irritable bowel syndrome or Crohn's disease
5. Women with untreated hyperparathyroidism
6. History of chronic antibiotic use
7. History of bariatric surgery
8. History of partial colectomy
9. History of problems with pancreas
10. History of history of chronic Hepatitis B or Hepatitis C, cirrhosis, fatty liver (nonalcoholic steatohepatitis; NASH) or chronic liver disease
11. History of problems with your heart valves, endocarditis, or previously had a valve replacement
12. Currently have problems with bone marrow such as myelodysplastic syndrome or anemia requiring transfusions
13. Women with spine abnormalities that would interfere with the assessment of BMD
14. Current smoking or use of nicotine products within the past 6-months
15. Major surgery or endoscopy within last 3 months
16. Coloscopy planned in the next 18-months and unwilling to reschedule it
17. Indwelling catheter, implanted hardware/prosthetic device or feeding tube
18. Any medical condition that could interfere with the conduct of the study
7. Treatment with calcitonin, estrogens, selective estrogen receptor modulators, progestins, anabolic steroids, or glucocorticoids in the past 6 months
8. Treatment with bisphosphonates in the past 3 yrs
9. Previous treatment with parathyroid hormone (PTH), abaloparatide, romosozumab or denosumab in the last year or current coumadin use.
10. Participation in other bone, diet, autoimmune, or GI related clinical trials in the last 6 months. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
11. Participants who plan on changing diet and/or exercise regime during trial participation.
12. Screening laboratory tests greater than upper normal limit (ULN) or less than lower normal limit (LLN):
* 25-hydroxy vitamin D \<20 ng/mL
* Renal dysfunction (eGFR ≤50 ml/min)
13. Seated blood pressure greater than equal to 160 mm Hg or seated diastolic BP greater than equal to 100mm Hg.
14. Short Blessed Test score \>10 or judged by the research staff as unable to follow the study protocol
15. Current treatment or previous with Glucagon-like peptide (GLP-1) agonists in the last one year.
16. Any other condition that in the opinion of the investigator or study clinician would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study.

Contacts and Locations

Study Contact

Shivani Sahni, PhD

CONTACT

617-971-5382

ShivaniSahni@hsl.harvard.edu

Evelyn O'Neill

CONTACT

617-697-6599

oneill@hsl.harvard.edu

Principal Investigator

Shivani Sahni, PhD

PRINCIPAL_INVESTIGATOR

Hebrew SeniorLife

Study Locations (Sites)

Hebrew SeniorLife

Roslindale, Massachusetts, 02131

United States

Collaborators and Investigators

Sponsor: Hebrew SeniorLife

Shivani Sahni, PhD, PRINCIPAL_INVESTIGATOR, Hebrew SeniorLife

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-12

Study Completion Date2028-04

Study Record Updates

Study Start Date2024-08-12

Study Completion Date2028-04

Terms related to this study

Keywords Provided by Researchers

Dietary probiotics
Dietary prebiotics
Gut microbiome
Older women
Randomized Controlled Trial

Additional Relevant MeSH Terms

Osteoporosis
Inflammation
Aging