Lactose IntoleranceLFNCT04531033
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
A study testing Lactobacillus acidophilus MPH734 in people with Lactose Intolerance, run by Lemuel W. Taylor IV at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Lactose Intolerance
- What is being tested?
- Lactobacillus acidophilus MPH734
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2020to 14 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Participant is or may be pregnant, is trying to become pregnant, or is breastfeeding;
- 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, Crohn's 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;
Show all 15Show fewer
- 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 [e.g., 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 participant's doctor recommends removal from the study;
- Participant fails to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mary Hardin-Baylor
Belton, Texas, 76513
About this study
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?
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.
Read the detailed description
Participants will be included and/or 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, Crohn's 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 [e.g., 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 participant's 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 (i.e., 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 creamer/cream 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 Challenge/Ingestion -> 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 Challenge/Ingestion 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 LT1/LT2 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 Challenge/Ingestion 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 LT1/LT2/LT3 testing (less treatment Dose + 30-minute seated pre- Lactose Challenge/Ingestion) Day 68 - Day 97 - 90-Day Treatment Phase
- Subjects perform weekly Lactose Challenge/Ingestion 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 LT1/LT2/LT3/LT4/ testing (less Treatment Dose + 30- minute seating pre- Lactose Challenge/ Ingestion)
- Conditions
- Lactose Intolerance
- Being tested
- Lactobacillus acidophilus MPH734, Placebo
- Keywords
- lactose intolerance, probiotic
- Medical subject headings
- Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus acidophilus MPH734Dietary supplement
Also called Lacto-FreedomTM, or LF
After supplementing with oral probiotics, it has been suggested that select probiotics capable of expressing Beta-glucosidase enzyme activity may likewise be effective treatment for lactose intolerance.
PlaceboDietary supplement
placebo made to match dietary supplement being tested.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Taken once prior to the first testing session, 3x a day every day for the 7 days of supplementation, and taken one last time during second testing session. Receives: Dietary Supplement: Placebo |
| Low dose 10 billion CFU per day | Experimental | Taken once prior to the first testing session, 3x a day every day for the 7 days of supplementation, and taken one last time during second testing session. Receives: Dietary Supplement: Lactobacillus acidophilus MPH734 |
| High dose 15 billion CFU per day | Experimental | Taken once prior to the first testing session, 3x a day every day for the 7 days of supplementation, and taken one last time during second testing session. Receives: Dietary Supplement: Lactobacillus acidophilus MPH734 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactobacillus Acidophilus MPH734's Effect on lactose digestion in individuals who identify as lactose sensitive, intolerant, or avoid dairy.
Primary outcome 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.
Measured: 97 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start25 Aug 2020
- Primary completion25 Aug 2021
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactose IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 treatments: low dose probiotic, high dose probiotic, placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lemuel W. Taylor IV
- Sponsor type
- University, hospital or other
- Collaborators
- Manzo Pharmaceuticals
- Responsible party
- Sponsor-investigator, Lemuel W. Taylor IV, University of Mary Hardin-Baylor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531033
- Sponsor's protocol ID
- LF-1
- Acronym
- LF
- Status last verified
- May 2024
- First submitted
- 18 Aug 2020
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT04531033
- Acronym / sponsor ID
- LF / LF-1
- Conditions
- Lactose Intolerance
- Keywords
- lactose intolerance, probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Lemuel W. Taylor IVUniversity, hospital or other
- Collaborators
- Manzo Pharmaceuticals
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and/or 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, Crohn's 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 [e.g., 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 participant's 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 (i.e., 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 creamer/cream 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 Challenge/Ingestion -> 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 Challenge/Ingestion 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 LT1/LT2 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 Challenge/Ingestion 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 LT1/LT2/LT3 testing (less treatment Dose + 30-minute seated pre- Lactose Challenge/Ingestion) Day 68 - Day 97 - 90-Day Treatment Phase
- Subjects perform weekly Lactose Challenge/Ingestion 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 LT1/LT2/LT3/LT4/ testing (less Treatment Dose + 30- minute seating pre- Lactose Challenge/ Ingestion)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 3 treatments: low dose probiotic, high dose probiotic, placebo
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTaken once prior to the first testing session, 3x a day every day for the 7 days of supplementation, and taken one last time during second testing session. |
| Low dose 10 billion CFU per day | Experimental | Dietary Supplement: Lactobacillus acidophilus MPH734Taken once prior to the first testing session, 3x a day every day for the 7 days of supplementation, and taken one last time during second testing session. |
| High dose 15 billion CFU per day | Experimental | Dietary Supplement: Lactobacillus acidophilus MPH734Taken once prior to the first testing session, 3x a day every day for the 7 days of supplementation, and taken one last time during second testing session. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (15 listed)
- Participant is or may be pregnant, is trying to become pregnant, or is breastfeeding;
- 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, Crohn's disease, or is, or has been prescribed to take prescription or over-the-counter medication for such;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus acidophilus MPH734Also: Lacto-FreedomTM, or LFAfter supplementing with oral probiotics, it has been suggested that select probiotics capable of expressing Beta-glucosidase enzyme activity may likewise be effective treatment for lactose intolerance. | Dietary supplement | High dose 15 billion CFU per day, Low dose 10 billion CFU per day |
| Placeboplacebo made to match dietary supplement being tested. | Dietary supplement | Placebo |
Primary outcome
Lactobacillus Acidophilus MPH734's Effect on lactose digestion in individuals who identify as lactose sensitive, intolerant, or avoid dairy.
Time frame: 97 days
Primary outcome 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Related trials for Lactose Intolerance
Not yet recruiting
Partially Hydrolysed Whey Based Formula in Differentiation Between Non IgE Gastrointestinal Cow's Milk Protein Allergy and Milk Intolerance
Cow Milk Protein Allergy, Cow Milk Intolerance
Recruiting
Milk for Diabetes Prevention
Lactose Intolerance, Lactose Intolerant
Enrolling by invitationObservational study
Lactose Intolerance and Intestinal Permability
Lactose Intolerance, Adult Type, Intestinal Permability
Not yet recruitingObservational study
Screening of Lactose Intolerance Among IBS Patients Diarrhea Dominant
Lactose Intolerance
RecruitingPhase 3
Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.
Irritable Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus acidophilus MPH734 in people with Lactose Intolerance, run by Lemuel W. Taylor IV at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactobacillus Acidophilus MPH734's Effect on lactose digestion in individuals who identify as lactose sensitive, intolerant, or avoid dairy. (time frame: 97 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.