A Bifido Bacteria to Improve Lactose Digestion and Tolerance

NCT05668468 | Unknown

• 1 other identifier: IRB-2021-1099
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

We want to determine if feeding a bifido bacteria that readily digests lactose and galactooligosacharides improves lactose digestion and tolerance through alteration of the microbiome.

Conditions

Lactose Intolerance

Outcome Measures

Primary Outcomes (2)

• Bifidus feeding will change lactose digestion

  difference in lactose maldigestion as measured by breath hydrogren following a lactose challenges on day 14 and day 28.

  14 days

• Bifidus feeding will change lactose intolerance symptoms

  differences in symptoms of flatulence, stomach discomfort, and diarrhea following lactose challenges on day 14 and day 28

  14 days

Secondary Outcomes (1)

• daily symptoms of lactose intolerance will be minimal following return to normal diet

  14 days

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Daily cellulose capsule

Other: Placebo cellulose capsule

Experimental Group

EXPERIMENTAL

Daily Bifidobacterium adolescentis IVS-1,capsule

Dietary Supplement: Bifidobacterium adolescentis IVS-1 capsule

Interventions

Bifidobacterium adolescentis IVS-1 capsule DIETARY_SUPPLEMENT

Daily Bifidobacterium adolescentis IVS-1 capsule containing up to 6x10 ninth cfu per capsule or daily cellulose capsule

Experimental Group

Placebo cellulose capsule OTHER

Daily cellulose capsule

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability/desire to provide informed consent
• Aged 18 to 65 years of age inclusive at screening
• Self report of lactose intolerance or lactose maldigestion
• Agrees to refrain from all other treatments and products used for dairy intolerance (e.g., Lactaid®, Dietary Supplements, probiotics) during study involvement
• Willing to return for all study visits and complete all study related procedures, including fasting before and during the hydrogen breath tests, and avoiding lactose in their diets (ex. milk, fluid, and soft dairy foods) for Days 1-28 of the study
• Able to understand and provide written informed consent in English

You may not qualify if:

• Allergic to milk
• Currently pregnant
• Currently lactating
• Cigarette smoking or other use of tobacco or nicotine containing products within 3 months of screening
• Diagnosed with any of the following disorders known to be associated with abnormal gastrointestinal motility such as; Gastroparesis, amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, alcoholism, uremia, malnutrition, or untreated hypothyroidism
• History of surgery that alters the normal function of the gastrointestinal tract including, but not limited to: gastrointestinal bypass surgery, bariatric surgery, gastric banding, vagotomy, fundoplication, pyloroplasty \[Note: history of uncomplicated abdominal surgeries such as removal of an appendix more than 12 months prior to screening will not be excluded\]
• Past or present : Organ transplant, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, Celiac disease, chronic constipation, diverticulosis, inflammatory bowel disease (IBD), ulcerative colitis (UC), Crohn's disease (CD), small intestine bacterial overgrowth syndrome (SIBO), gastroparesis, gastro-esophageal reflux disease (GERD), Irritable Bowel Syndrome (IBS) or any other medical condition with symptoms that could confound collection of adverse events.
• Active ulcers, or history of severe ulcers
• Diabetes mellitus (type 1 and type 2)
• Congestive Heart Failure (CHF)
• Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
• BMI \> 35 kg/m2
• Recent bowel preparation for endoscopic or radiologic investigation within four weeks of screening (e.g., colonoscopy prep)
• Use of concurrent therapy(ies) or other products (e.g., laxatives, stool softeners, Pepto Bismol®,Lactaid® Dietary Supplements, probiotics) used for symptoms of dairy intolerance within 7 days of screening
• Chronic antacid and/or PPI use

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907-2059, United States

RECRUITING

Related Publications (14)

• O'Sullivan MG, Thornton G, O'Sullivan GC, Collins JK. Probiotic bacteria: myth or realilty. Trends in Food Science & Technology. 2010; 3: 309-314

  BACKGROUND

• Fuller R, Gibson GR. Modification of the intestinal microflora using probiotics and prebiotics. Scand J Gastroenterol Suppl. 1997;222:28-31. doi: 10.1080/00365521.1997.11720714.

  PMID: 9145443 BACKGROUND

• Reid G. Safety of lactobacillus strains as probiotic agents. Clin Infect Dis. 2002 Aug 1;35(3):349-50. doi: 10.1086/342477. No abstract available.

  PMID: 12115112 BACKGROUND

• Kocian J. Further possibilities in the treatment of lactose intolerance--lactobacilli. Prakticky Lekar. 1994; 74: 212-214.

  BACKGROUND

• Sharma M, Wasan A, Sharma RK. Recent developments in probiotics: An emphasis on bifidobacterium. Food Bioscience. 2021;41: 100993.

  BACKGROUND

• Krumbeck JA, Maldonado-Gomez MX, Martinez I, Frese SA, Burkey TE, Rasineni K, Ramer-Tait AE, Harris EN, Hutkins RW, Walter J. In vivo selection to identify bacterial strains with enhanced ecological performance in synbiotic applications. Appl Environ Microbiol. 2015 Apr;81(7):2455-65. doi: 10.1128/AEM.03903-14. Epub 2015 Jan 23.

  PMID: 25616794 BACKGROUND

• Davis LM, Martinez I, Walter J, Hutkins R. A dose dependent impact of prebiotic galactooligosaccharides on the intestinal microbiota of healthy adults. Int J Food Microbiol. 2010 Dec 15;144(2):285-92. doi: 10.1016/j.ijfoodmicro.2010.10.007. Epub 2010 Oct 14.

  PMID: 21059476 BACKGROUND

• Leis R, de Castro MJ, de Lamas C, Picans R, Couce ML. Effects of Prebiotic and Probiotic Supplementation on Lactase Deficiency and Lactose Intolerance: A Systematic Review of Controlled Trials. Nutrients. 2020 May 20;12(5):1487. doi: 10.3390/nu12051487.

  PMID: 32443748 BACKGROUND

• Jiang T, Mustapha A, Savaiano DA. Improvement of lactose digestion in humans by ingestion of unfermented milk containing Bifidobacterium longum. J Dairy Sci. 1996 May;79(5):750-7. doi: 10.3168/jds.S0022-0302(96)76422-6.

  PMID: 8792277 BACKGROUND

• He T, Roelofsen H, Alvarez-Llamas G, de Vries M, Venema K, Welling GW, Vonk RJ. Differential analysis of protein expression of Bifidobacterium grown on different carbohydrates. J Microbiol Methods. 2007 May;69(2):364-70. doi: 10.1016/j.mimet.2007.02.008. Epub 2007 Feb 28.

  PMID: 17397953 BACKGROUND

• Hertzler SR, Savaiano DA. Colonic adaptation to daily lactose feeding in lactose maldigesters reduces lactose intolerance. Am J Clin Nutr. 1996 Aug;64(2):232-6. doi: 10.1093/ajcn/64.2.232.

  PMID: 8694025 BACKGROUND

• Hertzler SR, Savaiano DA, Levitt MD. Fecal hydrogen production and consumption measurements. Response to daily lactose ingestion by lactose maldigesters. Dig Dis Sci. 1997 Feb;42(2):348-53. doi: 10.1023/a:1018822103911.

  PMID: 9052518 BACKGROUND

• Brandao Gois MF, Sinha T, Spreckels JE, Vich Vila A, Bolte LA, Weersma RK, Wijmenga C, Fu J, Zhernakova A, Kurilshikov A. Role of the gut microbiome in mediating lactose intolerance symptoms. Gut. 2022 Jan;71(1):215-217. doi: 10.1136/gutjnl-2020-323911. Epub 2021 Mar 18. No abstract available.

  PMID: 34086598 BACKGROUND

• Vitellio P, Celano G, Bonfrate L, Gobbetti M, Portincasa P, De Angelis M. Effects of Bifidobacterium longum and Lactobacillus rhamnosus on Gut Microbiota in Patients with Lactose Intolerance and Persisting Functional Gastrointestinal Symptoms: A Randomised, Double-Blind, Cross-Over Study. Nutrients. 2019 Apr 19;11(4):886. doi: 10.3390/nu11040886.

  PMID: 31010241 BACKGROUND

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 Officials

• Dennis Savaiano, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis Savaiano, PhD

CONTACT

765 494 8228; savaiano@purdue.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: placebo of cellulose identical in size, shape and color to intervention bifidus
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 29, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)