Smart Underwear for Lactose Intolerance

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Maryland, College Park

Trial Summary

What is the purpose of this trial?The goal of this Interventional study is to validate the Smart Underwear device's ability to detect lactose intolerance by comparing its results to self-reported symptoms in adult participants aged 18 and above, divided equally between self-reported lactose-tolerant and lactose-intolerant individuals. The main questions it aims to answer are: Can the Smart Underwear device reliably measure flatus events after lactose consumption? Does the Microbiome Activity Index differentiate between responses to lactose and sucrose consumption? Researchers will compare participants consuming lactose (experimental arm) with their results after consuming sucrose (placebo arm) to see if the device detects increased flatus events and higher Microbiome Activity Index values in the lactose arm. Participants will: * Follow a low-fiber/low-FODMAP diet for four days. * Record meals using a food log and a custom smartphone app. * Wear the Smart Underwear device for 8 hours daily for three days. * Fast for 12 hours overnight, consume 20 grams of either lactose or sucrose dissolved in water, and continue fasting for an additional 4 hours. * Fast for 12 hours overnight, consume 20 grams of the carbohydrate they did not consume the first time (lactose or sucrose) dissolved in water, and continue fasting for an additional 4 hours. * Complete digestive symptom surveys after each carbohydrate intake. The randomized crossover design ensures that participants consume both lactose and sucrose on separate days, with blinding maintained for both participants and researchers.

Eligibility Criteria

This trial is for adults who either tolerate lactose well or are lactose intolerant, without any gastrointestinal disorders and not on prescription meds. They must be willing to consume both sucrose and lactose as part of the study.

Inclusion Criteria

Willing and able to consume sucrose and lactose

Determined to be lactose tolerant or lactose intolerant after completing an eligibility survey

I do not have any stomach or intestine problems.

+1 more

Exclusion Criteria

Experience gastrointestinal pain, bloating, or diarrhea when consuming garlic, onions, or leeks

Have ever had an anaphylactic reaction after eating or drinking anything

I am under 18 years old.

+2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Dietary Preparation

Participants follow a low-fiber/low-FODMAP diet for four days and record meals using a food log and a custom smartphone app

4 days

Device Testing

Participants wear the Smart Underwear device for 8 hours daily for three days while consuming lactose and sucrose on separate days

3 days

Daily monitoring

Follow-up

Participants complete digestive symptom surveys after each carbohydrate intake

1 day

Participant Groups

The study tests if Smart Underwear can detect flatus events and differentiate between responses to lactose (which some people can't digest) versus sucrose. Participants will follow a special diet, wear the device, and log their meals and symptoms.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment2 Interventions

Participants consume lactose and wear the Smart Underwear device

Group II: PlaceboPlacebo Group2 Interventions

Participants consume sucrose and wear the Smart Underwear device