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

NCT04531033 | Completed

• 1 other identifier: LF-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lactose Intolerance

Keywords

lactose intolerance; probiotic

Outcome Measures

Primary Outcomes (1)

• 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.

  97 days

Study Arms (3)

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.

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.

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.

Dietary Supplement: Lactobacillus acidophilus MPH734

Interventions

Lactobacillus acidophilus MPH734 DIETARY_SUPPLEMENT

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.

Also known as: Lacto-FreedomTM, or LF

High dose 15 billion CFU per day; Low dose 10 billion CFU per day

Placebo DIETARY_SUPPLEMENT

placebo made to match dietary supplement being tested.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Lemuel W. Taylor IV: lead
• Manzo Pharmaceuticals: collaborator

Study Sites (1)

University of Mary Hardin-Baylor

Belton, Texas, 76513, United States

Location

MeSH Terms

Conditions

Lactose Intolerance

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 3 treatments: low dose probiotic, high dose probiotic, placebo

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 28, 2020
• Study Start: August 25, 2020
• Primary Completion: August 25, 2021
• Study Completion: November 14, 2022
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (1)