Lactose IntolerancePROBIOLACNCT05367453
Effect of a Probiotic With High Beta-galactosidase Activity on Patients With Lactose Intolerance
A study testing Tropical juice with probiotics (B.coagulans), a Tropical juice with no probiotics and lactase tablet in people with Lactose Intolerance, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Lactose intolerance is a chronic disease caused by the total/partial lack of lactase production. When lactose is not properly digest, it is consumed by the microbiota. This situation presents different gastrointestinal symptoms such as meteorism, pain, bloating, diarrhoea and nausea. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lactose Intolerance
- What is being tested?
- Tropical juice with probiotics (B.coagulans), a Tropical juice with no probiotics and lactase tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 22 Feb 2021to 9 Feb 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women at 18-65 years of age
- Body Mass Index (BMI) ≥18,5 and <35 kg/m2
- Patients with lactose intolerance
- Patients with a social environment that do not prevent the clinical trial fulfillment
- Patients with proper cultural level and good understanding level about the clinical trial
- Patients that have voluntarily agreed to participate in the clinical trial, giving the written informed consent.
Who cannot join
- Patients with Body Mass Index (BMI) <18,5 or ≥35 kg/m2
- Patients with Diabetes Mellitus type 1 (DMI) or Diabetes Mellitus type 2 (DMII) with no treatment
- Patients diagnosed with metabolic syndrome
- Patients diagnosed with hyperthyroidism/hypothyroidism with no treatment
- Patients with eating disorders
- Patients with diagnosed mental disorder (dementia, any cognitive function decline)
Show all 31Show fewer
- Patients with celiac disease
- Patients with uncontrolled high blood pressure (last 2 months)
- Patients with serious disease (ascites, cirrhosis, kidney failure, heart failure, pseudomembranous colitis, lung failure, cancer, etc.)
- Patients with chronic inflammatory bowel disease (gastritis, ulcerative colitis, irritable bowel syndrome, Crohn disease, bowel perforation, etc.)
- Patients with glomerular filtration rate <90 ml/min/1,73 m2
- Patients with auto-immune diseases
- Patients undergoing corticosteroids or immunosuppressive treatment (last 12 months)
- Patients with recent episodes of nausea, vomits or diarrhoea (last 2 weeks)
- Patients with major surgery (last 3 months)
- Patients with gastrointestinal surgery (last 6 months)
- Patients with surgery for weight loss (gastric bypass, lap band)
- Patients on anticoagulation therapy
- Patients with diagnosed lactase congenital deficit
- Patients with fructose intolerance
- Patients with allergies to cow's milk protein
- Patients with intolerance to any of the ingredients of the clinical trial products.
- Patients with excessive exercise (>2h, thrice per week)
- Patients undergoing antibiotic treatment (last month)
- Patients with high consume of supplements (antioxidants, omega-3, vitamins, minerals, prebiotics) (last 2 weeks)
- Patients with regular consumption of fermented foods (≥3 times per week, such as yogurt, kefir, blue cheese) or probiotics.
- Patients with alcoholic consumptions > 30 g/d (i.e. 300 mL of wine, 3 bottles of beer, a cup of whiskey (75 mL) or similar distilled alcoholic beverages)
- Patients with regular use of laxatives (>2 per week)
- Patients participating in more clinical trials at the same time.
- Pregnant/breastfeeding women
- Women with regular use of contraception treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Clinical Trial to Evaluate the Regular Consumption Effect of a Probiotic With High Beta-galactosidase Activity Over Lactose Intolerance Gastrointestinal Symptoms in Patients With Lactose Intolerance
Lactose intolerance is a chronic disease caused by the total/partial lack of lactase production. When lactose is not properly digest, it is consumed by the microbiota. This situation presents different gastrointestinal symptoms such as meteorism, pain, bloating, diarrhoea and nausea. The dietetic treatment for this patients consists of avoiding lactose-rich foods, mainly milk and dairy products. However, nowadays exists a large diversity of lactose-free products specially focused on lactose intolerants. In this context, using B.coagulans as a probiotic in a food matrix could be an alternative for these patients, since its ability of spore forming and the production of beta-galactosidase.
Based on the foregoing, the group research has design a randomized, double-blind, placebo-controlled crossover nutritional clinical trial to evaluate the effect of a regular probiotic with high production of beta-galactosidase effect over gastrointestinal syntoms of patients with lactose intolerance.
Read the detailed description
Probiotics are defined by Food and Agriculture Organization of the United Nations and World Health Organization (FAO/WHO) as "living microorganisms that, properly administrated, confers a benefit on individual's health". Probiotics definition it's closely related to functional food concept, which encompasses either products or ingredients that are able to exert a positive impact on individual's health beyond their nutritional value. In fact, most of consumers in developed countries, strongly associate probiotics as functional foods. Lactic acid bacteria are the main microorganisms used as a probiotic, being Lactobacillus, Bifidobacterium, Propionibacterium and Streptococcus genus the most applied. Additionally, some Saccharomyces yeast may be used as probiotics.
However, a microorganism should present particular characteristic in human gastrointestinal's tract to be considered as a probiotic, following the Joint FAO/WHO Group directions: resistance to gastric and pancreatic secretions; adherence to intestinal epithelium and mucosa; antimicrobial activity against pathogenic bacteria; capability of reducing pathogen adhesion on intestinal epithelium; and present certain enzyme activity. The former bacteria genus fulfill most of the previous characteristics. However, these microorganism survival on gut is quite low (1-15%). For this reason, recent Works are searching for microorganism genus able to survive in a larger extend in gut.
Non-pathogenic bacteria of Bacillus genus have spore forming ability in the gastrointestinal tract. Specifically, Bacillus coagulans strain has been subject of new studies. B. coagulans has an optimal growth temperature of 35-50ºC, with pH conditions nearby 6. This microorganism consumes glucose, sucrose, maltose and mannitol while growing to produce lactic acid. In addition, B.coagulans is able to produce some enzymes (depending on the strain) such as alpha and beta-galactosidase, alpha-amylase, lipase and protease. However, the capability of growing in gut depends on time from its consumption (mostly oral) and the spore generation rate. The optimal dose is about 9,52x10e11 UFC, if an standard adult of 70 Kg is assumed. In addition, several studies have proved the B.coagulans ability of forming spores in presence of energy sources such as fructose and lactose.
Lactose intolerance is a chronic disease caused by the total/partial lack of lactase production. When lactose is not properly digest, it is consumed by the microbiota. This situation presents different gastrointestinal symptoms such as meteorism, pain, bloating, diarrhoea and nausea. The dietetic treatment for this patients consists of avoiding lactose-rich foods, mainly milk and dairy products. However, nowadays exists a large diversity of lactose-free products specially focused on lactose intolerants. In this context, using B.coagulans as a probiotic in a food matrix could be an alternative for these patients, since its ability of spore forming and the production of beta-galactosidase.
Based on the foregoing, the group research has designed a randomized, double-blind, placebo-controlled crossover nutritional clinical trial to evaluate the effect of a regular probiotic with high production of beta-galactosidase effect over gastrointestinal syntoms of patients with lactose intolerance.
- Conditions
- Lactose Intolerance
- Being tested
- Tropical juice with probiotics (B.coagulans), a Tropical juice with no probiotics, lactase tablet, placebo tablet (cornstarch)
- Medical subject headings
- Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tropical juice with probiotics (B.coagulans)Dietary supplement
Once a day during all the intervention phase, volunteers with lactose intolerance should allow the spore-forming ability of B. coagulans in order to digest lactase from dairy products through regular consumption of Tropical juice with probiotics (B.coagulans)
a Tropical juice with no probioticsOther
Once a day during all the intervention phase, volunteers with lactose intolerance should consume a Tropical juice with no probiotics
lactase tabletOther
lactase tablet
placebo tablet (cornstarch)Other
placebo tablet (cornstarch)
| Study group | Role | What they receive |
|---|---|---|
| Lactase | Active comparator | Volunteers will consume once a day for 1 month a tropical juice (orange, mango, pineapple and turmeric) and a lactase tablet Receives: Other: a Tropical juice with no probiotics; Other: lactase tablet |
| Probiotic | Experimental | Volunteers will consume once a day for 1 month the probiotic added to a liquid matrix (tropical juice) and and a placebo tablet (cornstarch) Receives: Dietary Supplement: Tropical juice with probiotics (B.coagulans); Other: placebo tablet (cornstarch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal symptoms
The questionnaire developed by Casellas et al. 2009 on the specific symptoms of lactose intolerance. The patient will indicate on a scale of 1 to 10 the intensity of the following gastrointestinal symptoms: abdominal pain, bloating, flatulence, diarrhea and cramps. The scale indicates the total absence of symptoms (0) or their severe presence (10).
Measured: 3 months
Secondary outcomes (6)
Sensory perception
It is evaluated using a visual analog scale (VAS) on different sensory aspects of the product: the desire to take it, taste, smell, consistency and effectiveness of its consumption. The scale analyzes values between 0% (most negative values) or 100% (extremely positive values).
Measured: 3 months
Physical activity
Use of International Physical Activity Questionnaire (IPAQ) to determine changes on physical activity during the clinical trial
Measured: 3 months
Waist circumference
Data referring to the waist circumference of the Spanish population allow to estimate cardiovascular risk parameters from 95 cm in men and 82 cm in women, and very high risk from 102 cm in men and 90 cm in women. The measurement is taken at the narrowest point between the last rib and the iliac crest, with the tape against the skin but not compressed. The person should be kept in an upright position, distributing the weight equally on both legs and their arms relaxed at the sides of the body.
Measured: 3 months
Body weight
Body weight is measured using a digital scale for clinical use (capacity 0 - 150 kg), with the person positioned with their back to the viewer, without shoes, with a minimum of warm clothing (pants and t-shirt), heels together, looking towards straight forehead and body posture.
Measured: 3 months
Digestive Symptoms Questionnaire (GSRS)
Assessment of digestive symptoms throughout the study. The questionnaire includes 15 items grouped into 5 blocks based on different gastrointestinal symptoms. The 5 groups of symptoms are: reflux, abdominal pain, indigestion, diarrhea and constipation. Subject is asked about pain or discomfort in the upper abdomen or pit of the stomach, heartburn, acid reflux, hunger, nausea, "gut rumbling," bloating, belching, farting, constipation , diarrhoea, loose or hard stools, an urgent need to have a bowel movement and a feeling of not having finished having a bowel movement. It is scored based on a 7-point Likert-type scale, where 1 represents the most positive option and 7 the most negative. The equivalence in this questionnaire would be: 1 asymptomatic; 2 slight discomfort; 3 mild symptoms; 4 moderate symptoms; 5 moderately severe symptoms; 6 severe symptoms; 7 very serious symptoms
Measured: 3 months
Changes in stool quality
Bristol scale to find out changes in stool form and stool frequency. The Bristol scale has 7 groups: types 1 and 2 are indicative of constipation, types 3 and 4 are desirable stools, especially 4, since they are the easiest to defecate, finally types 5, 6 and 7 are indicative diarrhea or cholera
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start22 Feb 2021
- Primary completion30 Nov 2021
- Study completion9 Feb 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Go Fruselva, S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367453
- Sponsor's protocol ID
- HULP 5758
- Acronym
- PROBIOLAC
- Status last verified
- Feb 2022
- First submitted
- 18 Apr 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Clinical Trial to Evaluate the Regular Consumption Effect of a Probiotic With High Beta-galactosidase Activity Over Lactose Intolerance Gastrointestinal Symptoms in Patients With Lactose Intolerance
- ClinicalTrials.gov ID
- NCT05367453
- Acronym / sponsor ID
- PROBIOLAC / HULP 5758
- Conditions
- Lactose Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Go Fruselva, S.L.
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 10 May 2022 (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.
Lactose intolerance is a chronic disease caused by the total/partial lack of lactase production. When lactose is not properly digest, it is consumed by the microbiota. This situation presents different gastrointestinal symptoms such as meteorism, pain, bloating, diarrhoea and nausea. The dietetic treatment for this patients consists of avoiding lactose-rich foods, mainly milk and dairy products. However, nowadays exists a large diversity of lactose-free products specially focused on lactose intolerants. In this context, using B.coagulans as a probiotic in a food matrix could be an alternative for these patients, since its ability of spore forming and the production of beta-galactosidase.
Based on the foregoing, the group research has design a randomized, double-blind, placebo-controlled crossover nutritional clinical trial to evaluate the effect of a regular probiotic with high production of beta-galactosidase effect over gastrointestinal syntoms of patients with lactose intolerance.
Detailed description
Probiotics are defined by Food and Agriculture Organization of the United Nations and World Health Organization (FAO/WHO) as "living microorganisms that, properly administrated, confers a benefit on individual's health". Probiotics definition it's closely related to functional food concept, which encompasses either products or ingredients that are able to exert a positive impact on individual's health beyond their nutritional value. In fact, most of consumers in developed countries, strongly associate probiotics as functional foods. Lactic acid bacteria are the main microorganisms used as a probiotic, being Lactobacillus, Bifidobacterium, Propionibacterium and Streptococcus genus the most applied. Additionally, some Saccharomyces yeast may be used as probiotics.
However, a microorganism should present particular characteristic in human gastrointestinal's tract to be considered as a probiotic, following the Joint FAO/WHO Group directions: resistance to gastric and pancreatic secretions; adherence to intestinal epithelium and mucosa; antimicrobial activity against pathogenic bacteria; capability of reducing pathogen adhesion on intestinal epithelium; and present certain enzyme activity. The former bacteria genus fulfill most of the previous characteristics. However, these microorganism survival on gut is quite low (1-15%). For this reason, recent Works are searching for microorganism genus able to survive in a larger extend in gut.
Non-pathogenic bacteria of Bacillus genus have spore forming ability in the gastrointestinal tract. Specifically, Bacillus coagulans strain has been subject of new studies. B. coagulans has an optimal growth temperature of 35-50ºC, with pH conditions nearby 6. This microorganism consumes glucose, sucrose, maltose and mannitol while growing to produce lactic acid. In addition, B.coagulans is able to produce some enzymes (depending on the strain) such as alpha and beta-galactosidase, alpha-amylase, lipase and protease. However, the capability of growing in gut depends on time from its consumption (mostly oral) and the spore generation rate. The optimal dose is about 9,52x10e11 UFC, if an standard adult of 70 Kg is assumed. In addition, several studies have proved the B.coagulans ability of forming spores in presence of energy sources such as fructose and lactose.
Lactose intolerance is a chronic disease caused by the total/partial lack of lactase production. When lactose is not properly digest, it is consumed by the microbiota. This situation presents different gastrointestinal symptoms such as meteorism, pain, bloating, diarrhoea and nausea. The dietetic treatment for this patients consists of avoiding lactose-rich foods, mainly milk and dairy products. However, nowadays exists a large diversity of lactose-free products specially focused on lactose intolerants. In this context, using B.coagulans as a probiotic in a food matrix could be an alternative for these patients, since its ability of spore forming and the production of beta-galactosidase.
Based on the foregoing, the group research has designed a randomized, double-blind, placebo-controlled crossover nutritional clinical trial to evaluate the effect of a regular probiotic with high production of beta-galactosidase effect over gastrointestinal syntoms of patients with lactose intolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactase | Active comparator | Other: a Tropical juice with no probiotics, Other: lactase tabletVolunteers will consume once a day for 1 month a tropical juice (orange, mango, pineapple and turmeric) and a lactase tablet |
| Probiotic | Experimental | Dietary Supplement: Tropical juice with probiotics (B.coagulans), Other: placebo tablet (cornstarch)Volunteers will consume once a day for 1 month the probiotic added to a liquid matrix (tropical juice) and and a placebo tablet (cornstarch) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women at 18-65 years of age
- Body Mass Index (BMI) ≥18,5 and <35 kg/m2
- Patients with lactose intolerance
- Patients with a social environment that do not prevent the clinical trial fulfillment
- Patients with proper cultural level and good understanding level about the clinical trial
Key exclusion criteria (31 listed)
- Patients with Body Mass Index (BMI) <18,5 or ≥35 kg/m2
- Patients with Diabetes Mellitus type 1 (DMI) or Diabetes Mellitus type 2 (DMII) with no treatment
- Patients diagnosed with metabolic syndrome
- Patients diagnosed with hyperthyroidism/hypothyroidism with no treatment
- Patients with eating disorders
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 |
|---|---|---|
| Tropical juice with probiotics (B.coagulans)Once a day during all the intervention phase, volunteers with lactose intolerance should allow the spore-forming ability of B. coagulans in order to digest lactase from dairy products through regular consumption of Tropical juice with probiotics (B.coagulans) | Dietary supplement | Probiotic |
| a Tropical juice with no probioticsOnce a day during all the intervention phase, volunteers with lactose intolerance should consume a Tropical juice with no probiotics | Other | Lactase |
| lactase tabletlactase tablet | Other | Lactase |
| placebo tablet (cornstarch)placebo tablet (cornstarch) | Other | Probiotic |
Primary outcome
Gastrointestinal symptoms
Time frame: 3 months
The questionnaire developed by Casellas et al. 2009 on the specific symptoms of lactose intolerance. The patient will indicate on a scale of 1 to 10 the intensity of the following gastrointestinal symptoms: abdominal pain, bloating, flatulence, diarrhea and cramps. The scale indicates the total absence of symptoms (0) or their severe presence (10).
6 secondary outcomes
Sensory perception
Time frame: 3 months
Physical activity
Time frame: 3 months
Waist circumference
Time frame: 3 months
Body weight
Time frame: 3 months
Digestive Symptoms Questionnaire (GSRS)
Time frame: 3 months
Changes in stool quality
Time frame: 3 months
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 10 May 2022.
- Individual participant dataSharing planned: No
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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 Tropical juice with probiotics (B.coagulans), a Tropical juice with no probiotics and lactase tablet in people with Lactose Intolerance, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 31 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 10 May 2022. 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 Spain. 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. 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?
Gastrointestinal symptoms (time frame: 3 months). 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 10 May 2022.