Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04531033
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2020-08-18
Brief Title:
Does Daily Supplementation of Lactobacillus Acidophilus MPH734 for One Week Affect Acute Immediate Subacute 7 Days and Post-treatment Discontinuation Lactose Metabolism Gastrointestinal Symptoms and Clinical Markers of Inflammation and Safety Compared to a Placebo
Sponsor:
Lemuel W Taylor IV
Organization:
University of Mary Hardin-Baylor
Study Overview
Official Title:
Does Daily Supplementation of Lactobacillus Acidophilus MPH734 Lacto-FreedomTM or LF for One Week Affects Acute Immediate Subacute 7 Days and Post-treatment Discontinuation 30- 60- and 90- Day Lactose Metabolism Gastrointestinal Symptoms and Clinical Markers of Inflammation and Safety Compared to a Placebo
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LF
Brief Summary:
The purpose of this study is to determine if twice or three times daily supplementation of Lactobacillus acidophilus MPH734 Lacto-FreedomTM or LF for one week affects acute immediate subacute 7 days and post-treatment discontinuation 30- 60- and 90- day lactose metabolism gastrointestinal symptoms and clinical markers of inflammation and safety compared to a placebo
Detailed Description:
Participants will be included andor excluded in the study based on the criteria below
Inclusion Criteria
Participants will be male or female between the ages of 18-55 years
Participants will be apparently healthy and free from disease as determined by a health history questionnaire
Participants will not be excluded if he or she has been clinically diagnosed with a carbohydrate malabsorption disorder or is or has been prescribed to take prescription or over-the-counter medication for such
Participant has self-diagnosed or otherwise avoids consuming dairy lactose and other dairy-containing products or regularly consumes Lactase enzymes for digestive support
Participant agrees and can comply with the study protocol
Participant provides signed and dated informed consent to participate in the study
Subject Exclusion Criteria
Participant is or may be pregnant is trying to become pregnant or is breastfeeding
Participant is insulin-dependent or -independent diabetic
Participant currently uses or has discontinued the use of nicotine-containing products within twelve 12 months of the start of the study
Participant lives or works within an environment that chronically exposes the subject to second-hand smoke
Participant currently uses or has discontinued the use of recreational drugs or medicinal marijuana within twelve 12 months of the start of the study
Participant has been clinically diagnosed with a digestive disorder such as gastrointestinal disease chronic diarrhea or constipation irritable or inflammatory bowel syndrome Crohns disease or is or has been prescribed to take prescription or over-the-counter medication for such
Participant has ever undergone gastric bypass surgery or has undergone an abdominal or other gastrointestinal surgery within twelve 12 months of the start of the study
Participant is taking or has taken antibiotic medications within two 2 weeks of the start of the study
Participant has undergone a colonoscopy within two 2 weeks of the start of the study or is scheduled to receive a colonoscopy during the study
Participant has undergone a barium study or received an enema within two 2 weeks of the start of the study or is scheduled to or receives such during the study
Participant is taking or has taken probiotics within two 2 weeks of the start of the study
Participant uses lactose digesting enzymes during the study
Participant is taking or has taken weight loss prebiotic eg fructo- or galacto-oligosaccharides FOS or GOS psyllium or insulin fiber etc or laxative stool softener dietary supplements over-the-counter or prescription medications within two 2 weeks of the start of the study
Participant is allergic to any ingredient present within the dietary supplement or placebo treatment
Participant reports any unusual adverse events associated with this study that in consultation with the study investigators or the participants doctor recommends removal from the body
Participant fails to comply with the study protocol
Intervention Below is an overview of the study including the phases timepoints and dependent variables that will be assessed The total study duration for each subject is approximately fifteen 15 weeks - one 1 week of pre-test familiarization plus fourteen 14 weeks of intervention and testing Subject testing will commence on a rolling enrollment basis ie all subjects will not start be tested on and end the study at the same time
24 hrs - 12 hrs Restricted Diet
Discontinue eating
All grains including pasta bread cereals
Fruits
Vegetables including any food products that contain corn corn starch etc
Nuts and seeds
Beans Legumes
All dairy products including cheese ice cream butter and yogurt
All meats except those approved below
Allowed foods
Baked or broiled chicken fish or turkey salt and pepper seasoning only
Plain steamed white rice
Eggs
Clear chicken or beef broth
White bread only
Participants may drink water coffee or tea no sugar or artificial sweetener no creamercream 12 hrs - 0 hrs Fasting
Water only
No sleeping or vigorous exercise for at least 1 hour prior to any time during the breath test
TIMELINE
Day -7 - 0 - Pre-screening Familiarization
Subjects complete one-week nutrition log via MyFitnessPal Day 0 - Baseline Acute Response Lab Test 1 LT1
Subject arrives 12-hr fasted water only and having followed the 24hr pre-test and lifestyle protocol - Body Mass BM and Hydration urine measurements - 5-minute seated - Heartrate HR and Blood Pressure BP measurements - Gastrointestinal Symptom Score - Venous Blood collection - Non-Alcohol Mouth Rinse - Breath Analysis - Treatment Dose Consumed with 8-10 fl oz H2O - 30- minute seated - 25-gram Lactose ChallengeIngestion - 60- minute seated - Non-Alcohol Mouth Rinse - Breath Analysis - 60-minute seated - Non-Alcohol Mouth Rinse - Breath Analysis - 60 minute seated - Gastrointestinal Symptoms Score - Non-Alcohol Mouth Rinse - Breath Analysis Day 1 - Day 7 - Treatment Phase
Subjects consume three 3 servings per day of treatment at scheduled times and conditions for three 3 days - On Day 4 subjects perform a Lactose Challenge Ingestion Test at home after a12-hr fast water only Gastrointestinal Symptoms Score is collected prior to and at 180 minutes postprandial after lactose ingestion - Subjects continue to consume three 3 servings per day of treatment at scheduled times and conditions for three 3 days
Subjects complete one-week nutrition log Day 7 - Subacute Response Lab Test 2 LT2
Repeat LT1
Subjects discontinue treatment Day 8 - Day 37 - 30- Day Post Treatment Phase
Subjects perform weekly Lactose ChallengeIngestion Testing at home with Gastrointestinal Symptoms Scoring
Subjects complete one-week nutrition logs Day 37 - 30-Day Post Treatment Response Lab Test 3 LT3
Repeat LT1LT2 testing less the Treatment Dose 30-minute seating pre-Lactose Challenge Ingestion Day 38 - Day 67 - 60-Day Post Treatment Phase
Subjects perform weekly Lactose ChallengeIngestion Testing at home with Gastrointestinal Symptoms scoring
Subjects complete one-week nutrition logs Day 67 - 60- Day Post Treatment Response Lab Test 4 LT4
Repeat LT1LT2LT3 testing less treatment Dose 30-minute seated pre- Lactose ChallengeIngestion Day 68 - Day 97 - 90-Day Treatment Phase
Subjects perform weekly Lactose ChallengeIngestion Testing at home with Gastrointestinal Symptoms Scoring
Subjects complete one-week nutrition logs Day 97 - 90-Day Post Treatment Response Lab Test 5 LT5
Repeat LT1LT2LT3LT4 testing less Treatment Dose 30- minute seating pre- Lactose Challenge Ingestion
Inclusion Criteria
Participants will be male or female between the ages of 18-55 years
Participants will be apparently healthy and free from disease as determined by a health history questionnaire
Participants will not be excluded if he or she has been clinically diagnosed with a carbohydrate malabsorption disorder or is or has been prescribed to take prescription or over-the-counter medication for such
Participant has self-diagnosed or otherwise avoids consuming dairy lactose and other dairy-containing products or regularly consumes Lactase enzymes for digestive support
Participant agrees and can comply with the study protocol
Participant provides signed and dated informed consent to participate in the study
Subject Exclusion Criteria
Participant is or may be pregnant is trying to become pregnant or is breastfeeding
Participant is insulin-dependent or -independent diabetic
Participant currently uses or has discontinued the use of nicotine-containing products within twelve 12 months of the start of the study
Participant lives or works within an environment that chronically exposes the subject to second-hand smoke
Participant currently uses or has discontinued the use of recreational drugs or medicinal marijuana within twelve 12 months of the start of the study
Participant has been clinically diagnosed with a digestive disorder such as gastrointestinal disease chronic diarrhea or constipation irritable or inflammatory bowel syndrome Crohns disease or is or has been prescribed to take prescription or over-the-counter medication for such
Participant has ever undergone gastric bypass surgery or has undergone an abdominal or other gastrointestinal surgery within twelve 12 months of the start of the study
Participant is taking or has taken antibiotic medications within two 2 weeks of the start of the study
Participant has undergone a colonoscopy within two 2 weeks of the start of the study or is scheduled to receive a colonoscopy during the study
Participant has undergone a barium study or received an enema within two 2 weeks of the start of the study or is scheduled to or receives such during the study
Participant is taking or has taken probiotics within two 2 weeks of the start of the study
Participant uses lactose digesting enzymes during the study
Participant is taking or has taken weight loss prebiotic eg fructo- or galacto-oligosaccharides FOS or GOS psyllium or insulin fiber etc or laxative stool softener dietary supplements over-the-counter or prescription medications within two 2 weeks of the start of the study
Participant is allergic to any ingredient present within the dietary supplement or placebo treatment
Participant reports any unusual adverse events associated with this study that in consultation with the study investigators or the participants doctor recommends removal from the body
Participant fails to comply with the study protocol
Intervention Below is an overview of the study including the phases timepoints and dependent variables that will be assessed The total study duration for each subject is approximately fifteen 15 weeks - one 1 week of pre-test familiarization plus fourteen 14 weeks of intervention and testing Subject testing will commence on a rolling enrollment basis ie all subjects will not start be tested on and end the study at the same time
24 hrs - 12 hrs Restricted Diet
Discontinue eating
All grains including pasta bread cereals
Fruits
Vegetables including any food products that contain corn corn starch etc
Nuts and seeds
Beans Legumes
All dairy products including cheese ice cream butter and yogurt
All meats except those approved below
Allowed foods
Baked or broiled chicken fish or turkey salt and pepper seasoning only
Plain steamed white rice
Eggs
Clear chicken or beef broth
White bread only
Participants may drink water coffee or tea no sugar or artificial sweetener no creamercream 12 hrs - 0 hrs Fasting
Water only
No sleeping or vigorous exercise for at least 1 hour prior to any time during the breath test
TIMELINE
Day -7 - 0 - Pre-screening Familiarization
Subjects complete one-week nutrition log via MyFitnessPal Day 0 - Baseline Acute Response Lab Test 1 LT1
Subject arrives 12-hr fasted water only and having followed the 24hr pre-test and lifestyle protocol - Body Mass BM and Hydration urine measurements - 5-minute seated - Heartrate HR and Blood Pressure BP measurements - Gastrointestinal Symptom Score - Venous Blood collection - Non-Alcohol Mouth Rinse - Breath Analysis - Treatment Dose Consumed with 8-10 fl oz H2O - 30- minute seated - 25-gram Lactose ChallengeIngestion - 60- minute seated - Non-Alcohol Mouth Rinse - Breath Analysis - 60-minute seated - Non-Alcohol Mouth Rinse - Breath Analysis - 60 minute seated - Gastrointestinal Symptoms Score - Non-Alcohol Mouth Rinse - Breath Analysis Day 1 - Day 7 - Treatment Phase
Subjects consume three 3 servings per day of treatment at scheduled times and conditions for three 3 days - On Day 4 subjects perform a Lactose Challenge Ingestion Test at home after a12-hr fast water only Gastrointestinal Symptoms Score is collected prior to and at 180 minutes postprandial after lactose ingestion - Subjects continue to consume three 3 servings per day of treatment at scheduled times and conditions for three 3 days
Subjects complete one-week nutrition log Day 7 - Subacute Response Lab Test 2 LT2
Repeat LT1
Subjects discontinue treatment Day 8 - Day 37 - 30- Day Post Treatment Phase
Subjects perform weekly Lactose ChallengeIngestion Testing at home with Gastrointestinal Symptoms Scoring
Subjects complete one-week nutrition logs Day 37 - 30-Day Post Treatment Response Lab Test 3 LT3
Repeat LT1LT2 testing less the Treatment Dose 30-minute seating pre-Lactose Challenge Ingestion Day 38 - Day 67 - 60-Day Post Treatment Phase
Subjects perform weekly Lactose ChallengeIngestion Testing at home with Gastrointestinal Symptoms scoring
Subjects complete one-week nutrition logs Day 67 - 60- Day Post Treatment Response Lab Test 4 LT4
Repeat LT1LT2LT3 testing less treatment Dose 30-minute seated pre- Lactose ChallengeIngestion Day 68 - Day 97 - 90-Day Treatment Phase
Subjects perform weekly Lactose ChallengeIngestion Testing at home with Gastrointestinal Symptoms Scoring
Subjects complete one-week nutrition logs Day 97 - 90-Day Post Treatment Response Lab Test 5 LT5
Repeat LT1LT2LT3LT4 testing less Treatment Dose 30- minute seating pre- Lactose Challenge Ingestion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None