Fructanase for Digestive Health

Overseen By John Marshall

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: BIO-CAT, Inc.

Must not be taking: Antibiotics, Steroids, Anti-inflammatories, others

Disqualifiers: GI conditions, Diabetes, Cancer, others

Compensation: Varies

Number of Visits: 3

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new enzyme called fructanase, which might reduce uncomfortable stomach issues like bloating and cramping after eating certain foods. These foods contain fructans, a type of carbohydrate found in wheat and vegetables, which can cause gas when broken down in the gut. Researchers aim for fructanase to lessen these symptoms and reduce gas production, measured through breath tests. This trial may suit individuals who frequently experience digestive issues after consuming meals high in fructans. Participants should have no major gastrointestinal conditions and must maintain their usual diet and health habits during the study. As an unphased trial, this study offers a unique opportunity to contribute to early-stage research and potentially benefit from a novel treatment for digestive discomfort.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications and supplements that affect digestive function, such as digestive enzymes, probiotics, fiber supplements, and some GI medications, at least 2 weeks before the study and throughout the study period.

What prior data suggests that fructanase is safe for digestive health?

Research has shown that fructanase is generally safe for people. In earlier studies, most participants experienced only mild side effects. Only one participant had a moderate, but not serious, side effect. This treatment was tested in healthy adults and found to be safe. It was well-tolerated when taken twice a day. These results suggest that fructanase could help those looking to reduce digestive issues from foods high in fructans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fructanase is unique because it specifically targets fructans, a type of carbohydrate that can cause digestive discomfort in some individuals. Unlike other treatments for digestive issues that may focus on general symptom relief, Fructanase directly breaks down fructans using inulinase activity, potentially offering a more targeted and effective solution. Researchers are excited about this treatment because it could provide relief for those who haven't found success with existing options that don't specifically address fructan digestion.

What evidence suggests that fructanase might be an effective treatment for GI symptoms?

Research has shown that fructanase, a digestive enzyme, might alleviate stomach issues like bloating and cramping caused by fructans. In lab studies, fructanase effectively broke down fructans, carbohydrates that often cause gas and discomfort due to their difficult digestion. Early results in people suggest that fructanase is safe and might ease these stomach problems. Some studies even found fewer side effects in those taking fructanase compared to those who did not. In this trial, participants will receive either fructanase or a placebo to evaluate its effectiveness. This enzyme could be a useful option for individuals who struggle to digest fructans in their diet. ^{2 3 6 7 8}

Who Is on the Research Team?

Aditi M. Shaw, MD

Principal Investigator

Biofortis, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 20-50 with a BMI of 18.5 to less than 30, who don't use tobacco or nicotine and can maintain their usual diet and weight during the study. They must not have health issues that could interfere with the trial, avoid certain medications and supplements, and give informed consent.

Inclusion Criteria

BMI ≥18.5 to less than 30.0 kg/m2 at Visit 1 (Day -7)

I am between 20 and 50 years old.

Willing to maintain habitual diet, physical activity, and body weight throughout the trial

Exclusion Criteria

Known sensitivity, intolerability, or allergy to any of the study products or their excipients

I do not have a severe GI condition that could affect the study's treatment evaluation.

Extreme dietary habits at the discretion of the Clinical Investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive fructanase or placebo with oatmeal and inulin, followed by GI symptom monitoring and breath analysis

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Questionnaires completed remotely

What Are the Treatments Tested in This Trial?

Interventions

• Fructanase

Trial Overview The trial tests if fructanase, a new digestive enzyme, can reduce gastrointestinal symptoms like bloating and gas after eating inulin-enriched oatmeal compared to a placebo (maltodextrin). It also measures breath hydrogen and methane as indicators of gut fermentation.

How Is the Trial Designed?

Group I: Fructanase Active Control 1 Intervention

Total 400 inulinase activity units (INU) per dose

Group II: Placebo Placebo Group 1 Intervention

Maltodextrin

Who Is Running the Clinical Trial?

BIO-CAT, Inc.

Lead Sponsor

Trials

6

Recruited

210+

Biofortis, Inc.

Collaborator

Trials

1

Recruited

30+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06628869

The Effects of Oral Fructanase Administration on ... A new digestive enzyme called fructanase was developed to help with GI symptoms associated with fructan consumption. Positive findings from in vitro digestion ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10251236/

Microbial inulinase promotes fructan hydrolysis under ... Exogenous supplementation with inulinase, fructanases, or fructose hydrolases may be useful for reducing the GI burden of FODMAPs in sensitive ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772572324000839

Safety and Tolerability of Microbial Inulinase ... The results from the present clinical trial show that microbial inulinase is safe and well-tolerated in healthy adults. Further research is warranted to assess ...

4. bmcmicrobiol.biomedcentral.com bmcmicrobiol.biomedcentral.com/articles/10.1186/s12866-023-03021-6

Combined oral intake of short and long fructans alters the gut ... The objective of this study was to assess the food allergy-preventive effects of combined intake of a short fructan (1-kestose [Kes]) and a long ...

5. nutritionaloutlook.com nutritionaloutlook.com/view/study-finds-that-enzyme-fructanase-which-may-help-with-digestion-of-high-fodmap-foods-is-safe-and-tolerable

Study finds that enzyme fructanase, which may help with ... Results shows that those taking the fructanase experienced fewer adverse events compared to placebo. More specifically, five participants in the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06628869?cond=Food%20fermentation&viewType=Table&rank=5

The Effects of Oral Fructanase Administration on ... We have also completed a Phase I clinical trial in healthy adults demonstrating the safety and tolerability of twice daily fructanase supplementation (total ...

7. bio-cat.com bio-cat.com/optiziome-fructanase/

OPTIZIOME® Fructanase BIO-CAT has developed a food-grade microbial fructanase into a novel dietary supplement ingredient to target fructan-type FODMAPs and help support digestive ...

8. ctv.veeva.com ctv.veeva.com/study/the-effects-of-oral-fructanase-administration-on-gastrointestinal-symptoms-after-inulin-challenge-in

The Effects of Oral Fructanase Administration on ... We have also completed a Phase I clinical trial in healthy adults demonstrating the safety and tolerability of twice daily fructanase ...