ClinicalTrials.gg
CompletedNCT01593800PLIUpdated Apr 6, 2016

The Effect of Probiotics on Lactose Intolerance

An interventional study of Bio-25 in Lactose Intolerance, sponsored by Rabin Medical Center. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-04-06.

Sponsored by Rabin Medical Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Lactose intolerance (LI), also known as lactose malabsorption is the most common type of carbohydrate malabsorption. It is associated with the inability to digest lactose into its constituents, glucose and galactose, due to low levels of lactase enzyme activity (1-2). At birth, lactase activity is at the highest and it declines after weaning (1-2). The unabsorbed lactose is metabolized by colonic bacteria to produce gas (hydrogen (H2) and methane (CH4)) and short chain fatty acids. Symptoms related to LI appear 30 minutes to 2 hours after consumption of food products containing lactose. Related symptoms include: bloating, cramping, flatulence and loose stool (1-2, 17-18).

Highest rates of LI are found in the Asian populations, Native Americans and African Americans (60-100%), while lowest rates are found in people of northern European origin (including northern Americans) (3-4).

The diagnosis of LI based on patients' symptoms is sometimes problematic, since these symptoms are not specific and may differ from one patient to another. Breath hydrogen test have been advocated as the best diagnostic tool for the assessment of LI (15-16). During the test, subjects are sampled for hydrogen levels of breath samples at base line and every 30 minutes after the administration of 50 grams of oral lactose, for a total period of 180 minutes. A breath sample with > 20 ppm above baseline is considered positive for LI (15-16).

There are no established treatments for LI, other than almost complete avoidance of lactose rich dairy products. Avoidance of dairy products is a major concern since its outcome may result in a dietary calcium intake that is well below recommended dose of 1,000 mg per day for men and women and 1,300 mg for adolescents (8-10). For this reason different course of action needs to be considered instead of a complete exclusion of dairy products by LI patients.

Two possible interventions in the case of LI are the supplement of commercially available lactase (tablets) or the addition of probiotics.

The consumption of lactase enzyme as a food supplement may assist in restoring adequate levels of the enzyme needed for hydrolysis of lactose, especially for patients with low, or non existent levels of lactase. On the other hand, lactase products are problematic since not all lactase preparations are of the same concentration. Moreover, it is difficult to asses the amount of lactase tablets needed in order do fully hydrolyze lactose in each dairy mill (14).

Probiotics are live microorganisms that are commonly used in order to prevent or treat a disease. The current definition by the Food and Drug Administration and the World Health Organization is "Live microorganisms which, when administered in adequate amounts, confer a health benefit on the host." These microorganisms are a heterogeneous group, they are nonpathogenic and produce beta- galactosidase or lactase intracellularly that may assist in the digestion of lactose (11).

Studies have shown that people with lactose intolerance tolerated the lactose in yogurt better than the same amount of lactose in milk. The assumption was that the presence of lactase producing bacteria in the yogurt, especially Lactobacillus acidophilus, contributed to the digestion and absorption of lactose (5-6, 13).

It was also found that the presence of Lactobacillus bulgaricus and Streptococcus thermophilus alleviate lactose intolerance through their ability to produce lactase enzyme (7).

Finally, in another study it was found that consumption of milk containing Bifidobacterium longum resulted in significantly less hydrogen production and flatulence as compared to the consumption of control pasteurized milk (12).

Based on the mentioned data, the investigators speculate that the administration of probiotics may assist with the consumption of dairy products containing lactose. Therefore, the aim of this study is to evaluate the effect of probiotics on patients with LI.

Read the detailed description

lactose hydrogen breath test (LHBT) will be performed at base line and at each visit (total of 7 breath samples from each patient). All subjects will be presented for the lactose hydrogen breath test after 8 hours fast.

At the initial stage, the subjects will take a base reading at time 0.

Subjects will then receive 50 g of lactose dissolved in a 100 ml of plain water and will perform further breath test samples every 30 minutes for 3 h. All breath samples will be end-expiratory and analyzed immediately by a Portable Breath Hydrogen Monitor (Gastro+ gastrolyzer, Bedfont Instruments, Holywell Lane, Upchurch, Kent, England). The concentration of breath hydrogen will be measured in parts per million (ppm). The measurements will then be plotted graphically and analyzed. The effect of probiotics on LI treatment will be measured by the following criteria:

  1. If hydrogen levels measured after 6 months of treatment will be lower than levels measured at time 0 and/or patients will report a decrease of symptoms, the treatment of LI with Probiotics will be considered successful.
  2. If hydrogen levels measured after 6 months of treatment will be the same or higher than levels measured at time 0 and/or patients will report an unchanged state or an increase of symptoms, the treatment of LI with probiotics will be considered unsuccessful.
02

Conditions studied

  • Lactose Intolerance

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Keywords

  • Probiotics
  • Lactose
03

In context

Lactose Intolerance

53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.

This study's enrollment of 60 is above the median of 41 across 41 interventional studies indexed under Lactose Intolerance.

Browse Lactose Intolerance studies →

Lead sponsor

Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • positive lactose hydrogen breath test (LHBT).

Exclusion criteria

Exclusion Criteria:

  1. Use of an antibiotic or Probiotics for more than 1 week before recruitment to the study
  2. Use of lactase
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    open label probiotics

    Bio-25 is an innovative formula containing 11 different strains of unique probiotic bacteria and over 25 billion active bacteria in each capsule. All participants will receive either Probiotics (Bio-25,will be provided by SupHerb) or placebo pills blindly for six months. One day prior to each visit, subjects will be asked to consume lactose, fructose and sorbitol free foods, in order to avoid high base line of hydrogen from the presence of unabsorbed carbohydrates. Subjects will also be asked not to smoke 24 hours prior to each visit.

    Dietary Supplement: Bio-25

Interventions

  • Dietary supplementBio-25

    Bio-25 is an innovative formula containing 11 different strains of unique probiotic bacteria and over 25 billion active bacteria in each capsule. All participants will receive either Probiotics (Bio-25,will be provided by SupHerb) or placebo pills blindly for six months. One day prior to each visit, subjects will be asked to consume lactose, fructose and sorbitol free foods, in order to avoid high base line of hydrogen from the presence of unabsorbed carbohydrates. Subjects will also be asked not to smoke 24 hours prior to each visit.

06

What researchers measure

Primary outcomes

  1. Change of hydrogen levels measured due to probiotics administration

    The effect of the probiotics on lactose intolerance will be evaluated through measurment of hydrogen levels (parts per million - ppm) at the end of each month of treatment. A decrease below cut off point of 20ppm will be considered as a successful outcome of the probiotics administration.

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2012, a primary completion of Oct 2014 and a completion of Apr 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 22, 2012
First posted
May 8, 2012
Start
May 2012
Primary completionActual
Oct 2014
CompletionActual
Apr 2015
Last update
Apr 6, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01593800
Collaborators
Ambrosia - SupHerb Ltd.
Responsible party
Sponsor
First posted
May 8, 2012
Start date
May 2012
Primary completion
Oct 2014
Completion
Apr 2015
Last update
Apr 6, 2016

Study contacts

Tsachi T Perets, PhD
study director · Rabin Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: BIO-25

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