Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560554
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Evaluating the Effects of a Fermented Diet on Microbiome Diversity in Individuals With Long COVID
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Effects of a Fermented Diet on Microbiome Diversity in Individuals With Long COVID
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effects of fermented foods on bacterial gut microbiome diversity of long-COVID subjects
Detailed Description:
This will be a single-center longitudinal randomized controlled trial assessing a high fermented food diet intervention among patients with long COVID
The investigators will adapt the high fermented food diet intervention previously described by Wastyk et al to our population of patients with long COVID A list of people meeting inclusion criteria who are open to research participation will be generated by the study team members working in the long COVID clinic eligible patients will be contacted by a different member of the study team not working in the long COVID clinic
Participants who agree to take part in the study will be randomized using REDCap into one of two arms a control arm no diet intervention or an intervention arm 20 participants will be assigned to each group 40 total The study will consist of 2 in-person visits at baseline and week 13 There will be weekly phone calls during weeks 1 through 12 for participants on the intervention arm participants in the control arm will be contacted as needed to ensure that they continue to document their diet three days a week
All participants will provide a total of two stool samples baseline and week 13 and undergo psychometric evaluation with Hospital Anxiety and Depression Scale HADS AD Impact of Event Scale - revised IES-R Montreal Cognitive Assessment MoCA-blind and European Quality of Life 5 Dimensions 5 Level Version EuroQol-5D-5L baseline and week 13 Demographic information on the subjects will also be collected age gender past medical history including mental health diagnoses or cognitive diagnoses time of COVID infection etc
During the baseline visit the investigators will interview all study participants and ask participants to provide details about their diet and any use of probiotic foods or supplements All participants will install the food tracking application Mayo Clinic Diet App on their personal smart device and will receive instructions on how to use it by a study team member An account for each participant will be set up by the study team and participants will be given a username and password The investigators will have access to the data entered Participants will be instructed to document their food intake at least three days every week two weekdays and one weekend day as was done in the study by Wastyk et al After the study participants may change their password if they would like to continue food tracking
Intervention Group
Participants assigned to the intervention arm will receive an in-person teaching session delivered by a trained team member The session will include introductory education on microbiome and a description on a variety of probiotic fermented foods commercially available fermented dairy products fermented vegetables fermented non-alcoholic drinks Participants will be able to choose their own probiotic fermented foods based on this education and taste preference
After the visit intervention arm participants will begin to incorporate probiotic fermented foods into their diet during weeks 1-4 of the study ramp up phase Participants will start with one serving of fermented food of their choice a day increasing to 6day as tolerated by the end of week 4 Weeks 5-12 will serve as the intervention maintenance phase with the target of a daily intake of 6 servings per day of fermented foods
Fermented food intake will be reported as the average number of servings per day for each week of the intervention One serving of probiotic fermented foods will be defined as kombucha yogurt kefir buttermilk kvass other probiotic fermented liquids 6 oz kimchi sauerkraut other probiotic fermented veggies 14 cup vegetable brine drinkgut shot from approved list 2 oz
Food logs will be reviewed by the investigators to assess compliance and provide recommendations to increase amounts or variety of fermented foods in the diet as tolerated Investigators will interact weekly with participants in the intervention arm by phone or zoom to review probiotic fermented food intake answer questions inquire about any gastrointestinal symptoms such as bloating or upset stomach and provide motivation to continue with the diet Study participants in the intervention arm will also be asked to assess their overall compliance with the diet on a scale of 0-10 with zero being not at all and 10 being exactly as recommended during the specific phase of the study
Control Group
The participants in the control arm will only complete the baseline and week 13 visits Participants in the control arm will be contacted as needed to ensure that they document their regular food intake 3 days a week Control group participants will not be asked to make any changes to their diet only to document their regular diet 3 days a week
At approximately 13 weeks all participants will collect and return a stool sample and repeat the study questionnaires Participants will be able to complete the questionnaires in person virtually or by phone
The investigators will adapt the high fermented food diet intervention previously described by Wastyk et al to our population of patients with long COVID A list of people meeting inclusion criteria who are open to research participation will be generated by the study team members working in the long COVID clinic eligible patients will be contacted by a different member of the study team not working in the long COVID clinic
Participants who agree to take part in the study will be randomized using REDCap into one of two arms a control arm no diet intervention or an intervention arm 20 participants will be assigned to each group 40 total The study will consist of 2 in-person visits at baseline and week 13 There will be weekly phone calls during weeks 1 through 12 for participants on the intervention arm participants in the control arm will be contacted as needed to ensure that they continue to document their diet three days a week
All participants will provide a total of two stool samples baseline and week 13 and undergo psychometric evaluation with Hospital Anxiety and Depression Scale HADS AD Impact of Event Scale - revised IES-R Montreal Cognitive Assessment MoCA-blind and European Quality of Life 5 Dimensions 5 Level Version EuroQol-5D-5L baseline and week 13 Demographic information on the subjects will also be collected age gender past medical history including mental health diagnoses or cognitive diagnoses time of COVID infection etc
During the baseline visit the investigators will interview all study participants and ask participants to provide details about their diet and any use of probiotic foods or supplements All participants will install the food tracking application Mayo Clinic Diet App on their personal smart device and will receive instructions on how to use it by a study team member An account for each participant will be set up by the study team and participants will be given a username and password The investigators will have access to the data entered Participants will be instructed to document their food intake at least three days every week two weekdays and one weekend day as was done in the study by Wastyk et al After the study participants may change their password if they would like to continue food tracking
Intervention Group
Participants assigned to the intervention arm will receive an in-person teaching session delivered by a trained team member The session will include introductory education on microbiome and a description on a variety of probiotic fermented foods commercially available fermented dairy products fermented vegetables fermented non-alcoholic drinks Participants will be able to choose their own probiotic fermented foods based on this education and taste preference
After the visit intervention arm participants will begin to incorporate probiotic fermented foods into their diet during weeks 1-4 of the study ramp up phase Participants will start with one serving of fermented food of their choice a day increasing to 6day as tolerated by the end of week 4 Weeks 5-12 will serve as the intervention maintenance phase with the target of a daily intake of 6 servings per day of fermented foods
Fermented food intake will be reported as the average number of servings per day for each week of the intervention One serving of probiotic fermented foods will be defined as kombucha yogurt kefir buttermilk kvass other probiotic fermented liquids 6 oz kimchi sauerkraut other probiotic fermented veggies 14 cup vegetable brine drinkgut shot from approved list 2 oz
Food logs will be reviewed by the investigators to assess compliance and provide recommendations to increase amounts or variety of fermented foods in the diet as tolerated Investigators will interact weekly with participants in the intervention arm by phone or zoom to review probiotic fermented food intake answer questions inquire about any gastrointestinal symptoms such as bloating or upset stomach and provide motivation to continue with the diet Study participants in the intervention arm will also be asked to assess their overall compliance with the diet on a scale of 0-10 with zero being not at all and 10 being exactly as recommended during the specific phase of the study
Control Group
The participants in the control arm will only complete the baseline and week 13 visits Participants in the control arm will be contacted as needed to ensure that they document their regular food intake 3 days a week Control group participants will not be asked to make any changes to their diet only to document their regular diet 3 days a week
At approximately 13 weeks all participants will collect and return a stool sample and repeat the study questionnaires Participants will be able to complete the questionnaires in person virtually or by phone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None