DigeZyme® and LactoSpore® Explained: What the Clinical Studies Actually Show
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Digestive enzymes and probiotics are often placed in the same gut-health basket, but they do not perform the same job.
DigeZyme® is a branded complex containing five digestive enzymes that help break down major components of food. LactoSpore® is a branded, spore-forming probiotic preparation containing the specific strain Bacillus coagulans MTCC 5856.
Both ingredients have been evaluated in human studies. However, the number, design, dosage and limitations of those studies matter. This guide examines what the research actually found, without stretching ingredient-level evidence into finished-product promises.
Quick answer: what does the research show?
DigeZyme® has one directly relevant randomized, placebo-controlled human study in adults with functional dyspepsia. LactoSpore® has several small human studies, including research on functional gas and bloating, diarrhoea-predominant irritable bowel syndrome, short-term safety and gut-microbiota composition.
Most of these studies were conducted or authored wholly or partly by researchers affiliated with Sami-Sabinsa, the developer and manufacturer of the ingredients. This does not make the findings invalid, but the commercial relationship should be considered when interpreting the evidence.
| Ingredient | Principal study | Studied amount | Duration |
|---|---|---|---|
| DigeZyme® | 40 adults with functional dyspepsia | 50 mg three times daily | 60 days |
| LactoSpore® | 70 adults with functional gas and bloating | 2 billion spores daily | 4 weeks |
What is DigeZyme®?
DigeZyme® is a proprietary multi-enzyme complex containing five digestive enzymes:
- Amylase: helps break down starches and carbohydrates.
- Protease: helps break down dietary proteins into smaller peptides and amino acids.
- Lipase: helps break down dietary fats.
- Cellulase: helps break down cellulose found in plant foods.
- Lactase: helps break down lactose, the naturally occurring sugar in dairy.
Because an everyday mixed meal may contain carbohydrates, protein, fat, fibre and dairy at the same time, the five enzymes are designed to perform different but complementary digestive functions.
What did the principal DigeZyme® study examine?
A 2018 randomized, double-blind, placebo-controlled study enrolled 40 adults with functional dyspepsia. Twenty participants received the multi-enzyme complex and twenty received placebo.
The enzyme group received 50 mg three times daily, equal to a total of 150 mg per day, for 60 days. The researchers assessed digestive symptoms and quality-of-life measurements using several questionnaires and rating scales.
The researchers reported greater improvements in several symptom measurements in the enzyme group compared with placebo. No product-related adverse events were reported during the study.
Important limitations of the DigeZyme® evidence
- The trial included only 40 participants.
- It examined adults with functional dyspepsia rather than the general population.
- The study used 150 mg per day, divided across three doses.
- The authors were founders or employees of Sami Labs or Sabinsa, the ingredient manufacturer.
- A large independent replication of the branded ingredient was not identified.
The study therefore provides preliminary human evidence for DigeZyme® under specific research conditions. It does not establish that every product or dosage containing DigeZyme® will produce identical results.
Are there other DigeZyme® studies?
A small study involving 20 healthy men evaluated DigeZyme® after exercise-induced muscle soreness. Participants received 50 mg three times daily for three days. Some subjective pain and muscle-tenderness measurements improved, but muscle power and grip strength did not show significant improvement.
Because this was a small, short sports-recovery study rather than a digestive-health study, it should not be used as the main evidence for a post-meal gut-health supplement.
Sabinsa also describes a five-day pilot assessment of vitamin C and beta-carotene bioavailability. However, a complete peer-reviewed publication containing the full methodology and results was not identified. A separate metabolic-health trial was registered, but published results were not identified. These should not be treated as confirmed efficacy evidence.
What is LactoSpore®?
LactoSpore® is a branded probiotic preparation containing the strain Bacillus coagulans MTCC 5856. It is a spore-forming probiotic, meaning the microorganism can remain in a protective spore state during storage and exposure to difficult environmental conditions.
The strain identifier MTCC 5856 matters. Probiotic research is strain-specific, so findings from one Bacillus coagulans strain cannot automatically be applied to every probiotic carrying the same species name.
What did the functional gas and bloating study find?
A 2023 multicentre, randomized, double-blind, placebo-controlled study enrolled 70 adults experiencing functional gas and bloating.
Participants received either:
- 2 billion spores of Bacillus coagulans MTCC 5856 daily, or
- A placebo for four weeks.
Sixty-six participants completed the study. The researchers reported a larger improvement in gastrointestinal symptom scores, including measurements related to gas, abdominal distension, burping and flatulence, in the probiotic group than in the placebo group.
No serious product-related safety concerns were reported during the trial.
Important limitations of the gas and bloating study
- The study population was relatively small.
- The trial was conducted at two centres in South India.
- The intervention lasted only four weeks.
- The study did not establish whether improvements continued after supplementation stopped.
- All authors were affiliated with Sami-Sabinsa or Sabinsa.
The results provide strain-specific human evidence for LactoSpore® at 2 billion spores daily under the study conditions. They should not be interpreted as a guarantee that every person will experience the same outcome.
What other human evidence is available for LactoSpore®?
Diarrhoea-predominant IBS pilot study
A 2016 pilot study enrolled 36 adults with newly diagnosed diarrhoea-predominant irritable bowel syndrome. Participants received 2 billion CFU of MTCC 5856 or placebo daily for 90 days.
The probiotic group reported improvements in several symptom and quality-of-life measurements. However, both groups also received standard medical treatment. This makes it harder to isolate how much of the outcome came from the probiotic itself.
The study is supportive, but it should not be used to claim that a consumer supplement treats or cures IBS.
Healthy-adult gut-microbiota study
A 2023 study evaluated 2 billion CFU daily for 28 days in 30 healthy adults. The researchers found no major disruption of the participants’ overall gut-microbiota composition. Some changes were observed in selected bacterial groups, while general health and laboratory safety measurements remained normal.
This study is better interpreted as evidence of short-term tolerability and microbiome stability in healthy adults, rather than proof that the strain dramatically changes the microbiome.
Short-term safety study
A separate randomized study evaluated 2 billion CFU daily for 30 days in 40 healthy adults. Laboratory parameters, vital signs and bowel measurements remained within normal clinical ranges, and the ingredient was reported to be generally well tolerated under the study conditions.
What do the stability studies tell us?
Laboratory and food-processing studies have evaluated the ability of Bacillus coagulans MTCC 5856 to remain viable during storage, exposure to heat and simulated gastrointestinal conditions.
These studies help explain why a spore-forming probiotic can be useful in shelf-stable supplement and food formulations. However, stability evidence is not the same as evidence of a health outcome in humans. Surviving processing or simulated stomach conditions does not, by itself, prove a clinical benefit.
How does this research compare with QIA Digest Biome?
QIA Digest Biome provides:
- 100 mg DigeZyme® per serving
- 2 billion CFU LactoSpore® per serving
- One capsule per serving
The main DigeZyme® digestive study used 150 mg per day, divided into three doses. Digest Biome contains 100 mg in one daily serving. QIA can therefore state that the formula contains a clinically studied branded enzyme complex, but it should not describe 100 mg as the clinically studied DigeZyme® dosage from that trial.
The 2 billion CFU amount of LactoSpore® in Digest Biome aligns with the daily amount evaluated in the functional gas and bloating, IBS-D and short-term safety studies.
However, these were studies of the individual branded ingredients. The complete Digest Biome combination has not itself been evaluated in a finished-product clinical trial.
Digest Biome is also third-party laboratory tested for relevant quality and safety parameters. Consumers can view the Digest Biome laboratory report here.
What does “clinically studied ingredient” mean?
A clinically studied ingredient has been evaluated in human research under defined conditions.
It does not automatically mean:
- Every dosage has been clinically evaluated.
- Every product containing the ingredient has been clinically tested.
- The same outcome will occur in every individual.
- The ingredient can diagnose, treat or cure a medical condition.
- Diet, meal size, hydration and lifestyle no longer matter.
Responsible evidence-based communication should identify the exact ingredient or probiotic strain, the amount studied, the participant group, the duration and any important limitations.
DigeZyme® vs LactoSpore®: what is the difference?
| DigeZyme® | LactoSpore® |
|---|---|
| Digestive-enzyme complex | Strain-specific probiotic preparation |
| Contains five enzymes | Contains Bacillus coagulans MTCC 5856 |
| Supports the breakdown of meal components | Provides probiotic support |
| Not a probiotic | Not a digestive enzyme |
The two ingredients are complementary rather than interchangeable. For a simpler introduction to the difference, read our digestive enzymes versus probiotics guide.
Frequently asked questions
Are DigeZyme® and LactoSpore® clinically proven?
Both ingredients have been evaluated in human studies. “Clinically studied” is the more accurate description. The current evidence does not justify promising a guaranteed result for every consumer or every finished product containing the ingredients.
Does Digest Biome use the same amounts as the studies?
Digest Biome provides 2 billion CFU of LactoSpore®, which matches the daily amount used in several cited LactoSpore® studies. It provides 100 mg DigeZyme®, while the principal DigeZyme® digestive study used a total of 150 mg per day.
Why does the probiotic strain number matter?
Probiotic effects can differ between strains of the same species. MTCC 5856 identifies the exact strain evaluated in the LactoSpore® research.
Can digestive enzymes and probiotics be taken together?
They can be included in the same formula because they perform different roles. Digestive enzymes act on components of a meal, while a probiotic provides strain-specific microbial support.
Has QIA Digest Biome itself been clinically tested?
No completed clinical trial of the finished Digest Biome formula is being claimed. Digest Biome contains individually studied branded ingredients and is third-party laboratory tested as a finished product.
Is Digest Biome intended to treat IBS or another digestive disease?
No. Digest Biome is a food supplement designed for post-meal digestive support. Persistent, severe or recurring symptoms should be assessed by a qualified healthcare professional.
The bottom line
DigeZyme® and LactoSpore® have different but complementary functions.
DigeZyme® contains five enzymes associated with the breakdown of protein, carbohydrates, fats, fibre and lactose. Its principal digestive study provides preliminary human evidence, although it was small, manufacturer-affiliated and used a higher total daily amount than Digest Biome.
LactoSpore® contains the strain Bacillus coagulans MTCC 5856. It has been evaluated at 2 billion CFU daily in several small human studies, including research involving functional gas and bloating, IBS-D, healthy adults and short-term safety.
The evidence supports describing both as clinically studied branded ingredients. It does not support describing the complete Digest Biome formula as clinically proven.
References
- Evaluation of the Safety and Efficacy of a Multienzyme Complex in Patients with Functional Dyspepsia. Journal of Medicinal Food. 2018.
- The Effects of Bacillus coagulans MTCC 5856 on Functional Gas and Bloating in Adults. Medicine. 2023.
- Bacillus coagulans MTCC 5856 Supplementation in Diarrhoea-Predominant Irritable Bowel Syndrome. Nutrition Journal. 2016.
- Probiotic Modulation of Gut Microbiota by Bacillus coagulans MTCC 5856 in Healthy Subjects. Medicine. 2023.
- A Double-Blind, Placebo-Controlled Study Evaluating the Safety of Bacillus coagulans MTCC 5856 in Healthy Individuals. Journal of Clinical Toxicology. 2016.
- Comparative Evaluation for Thermostability and Gastrointestinal Survival of Bacillus coagulans MTCC 5856. Bioscience, Biotechnology, and Biochemistry. 2021.
This article is for general educational purposes only and is not intended to diagnose, treat, cure or prevent any disease. Consult a qualified healthcare professional regarding persistent digestive symptoms, medical conditions, pregnancy, breastfeeding or medication use.