MAOGIT Screening - RDC Clinical

MAOGIT | Screening Script

"*" indicates required fields

Are you located in Brisbane or Sydney?

TC - if the participant is in Sydney, please check that they have the MAOGIT_Sydney tag in Active Campaign

Brisbane

Sydney

This study aims to assess the effectiveness of Maolactin : a protein product derived from bovine colostrum, for improving gastrointestinal health symptoms.

For this study we are looking to enrol 90 adults aged over 18 who are experiencing moderate GI disturbances of the upper GI tract such as reflux, heartburn, regurgitation, nausea, bloating, abdominal pain at least once a week over the last 3 months.

Before the study begins, there's a 1 month pre-study period where participants will asked to complete some questionnaires, a diet diary, collect a stool sample and conduct an extended urine test from home as part of the pre-study data collection period.

Faecal and urine sample collection kits will be posted to you after enrolment. Your urine sample will need to be collected over a period of 6 hours, but can be be done easily from home or anywhere that you have access to a private bathroom. We will guide you through the process and timing via text and email.

Once all your pre-study requirements are completed, you'll attend our clinic in Fortitude Valley for a 30 minute appointment that will include a fasted blood test.
You will be randomised on a chance basis to one of three different groups and allocated your trial product. You will be assigned to 1 of 3 groups:
Group 1 - High dose active group and being allocated the high dose product (500mg/day MaolactinTM)
Group 2- Low dose active group and being allocated the low dose product (250mg/day MaolactinTM)
Group 3 - Placebo group and being allocated the placebo product (0mg/day MaolactinTM)

We won't know which group you are in until the end of the study.

You will take your study product each day for 8 weeks. We'll ask you to complete more questionnaires and diet diaries during this time, and we'll keep in touch to make sure everything is going smoothly.
After 8 weeks on the study product, we'll ask you to repeat the stool and urine samples from your baseline timepoint and then return to our clinic for a final appointment and bloodtest.

Do you have any questions?

This study aims to assess the effectiveness of Maolactin : a protein product derived from bovine colostrum, for improving gastrointestinal health symptoms.

Before the study begins, there's a 28 day pre-study period where participants will asked to complete some questionnaires, a diet diary, collect and post stool and urine samples and attend the Norwest or Darlinghurst (Lvl3, 393 Bourke St) ACL clinic for a pathology test and some basic measurements.
Will you be able to attend one of these ACL locations for your blood test?

Your study product, Faecal and urine sample collection kits will be posted to you after enrolment. Your urine sample will need to be collected over a period of 6 hours, but can be be done easily from home or anywhere that you have access to a private bathroom. We will guide you through the process and timing via text and email.

Please do not start your study product until instructed by your Trial Coordinator as there are a number of tasks that will need to be completed first.

You will be randomised on a chance basis to one of three different groups and allocated your trial product. You will be assigned to 1 of 3 groups:
Group 1 - High dose active group and being allocated the high dose product (500mg/day MaolactinTM)
Group 2- Low dose active group and being allocated the low dose product (250mg/day MaolactinTM)
Group 3 - Placebo group and being allocated the placebo product (0mg/day MaolactinTM)

We won't know which group you are in until the end of the study.

You will take your study product each day for 8 weeks. We'll ask you to complete more questionnaires and diet diaries during this time, and we'll keep in touch to make sure everything is going smoothly.
After 8 weeks on the study product, we'll ask you to collect some final stool samples and then return to ACL for a final blood test.

Do you have any questions?

Trial Coordinator*

Participant still interested after study summary?*

Yes

Initials of the participant that is not interested...

Screening Questions

Gender

Female

Male

Are you aged over 18?

Yes

Not Eligible

Are you experiencing one or more symptoms of the upper GI tract (eg. reflux, heartburn, regurgitation, nausea, bloating, abdominal pain) at least once a week over the last 3 months?

Yes

Not Eligible

Please list symptoms and frequency

Height in metres

Weight in Kgs

BMI (must be under 35)

Not Eligible

Are you currently participating in any other clinical trials?

Yes

Not Eligible

Do you agree not to participate in any other trials whilst enrolled in this one?

Yes

Not Eligible

Do you have a normal diet?

(no FODMAP diet, elimination diet, vegan diet, etc) with a minimum 2-month period of self-reported dietary stability.)

Yes

Not Eligible

Do you have any unstable or serious illnesses?

(e.g. serious mood disorders such as depression or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, thyroid gland dysfunction, hypercholesterolemia)
History of bowel constriction
Controlled diabetes ok but participants will be excluded from the urine test

Yes

Not Eligible

Please list any medications, vitamins or supplements that you take regularly

Excluded - Proton pump inhibitors [e.g., Somac (pantoprazole), Pariet (rabeprazole), Losec (omeprazole)] or any anticoagulation or antiplatelet medications [e.g., Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin, dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), betrixaban (Bevyxxa), clopidogrel (Plavix), prasugrel (Effient), ticagrelor (Brilinta), cilostazol (Pletal) and dipyridamole (Attia, Ofcram, Persantin, Persantin Retard, Trolactin)] including low dose aspirin (acetylsalicylic acid). Dietary supplements for gut health or digestive enzymes.

Name of product

Dose/Frequency

Length of use

Was this prescribed by a health professional? (Y/N/Recommended)

Do you agree not to take dietary supplements for gut health or digestive enzymes during the study period?

Yes

Not Eligible

Do you agree not to change your diet or exercise routine during the study period?

Yes

Not Eligible

Do you or have you in the past experienced any serious GIT conditions such as inflammatory bowel disease, celiac disease or cystic fibrosis as well or gastrointestinal tract surgery?

Yes

Not Eligible

Have you had treatment for cancer in the last 2 years?

non-melanoma skin cancers not requiring radiation or chemotherapy are OK

Yes

Not Eligible

If you are of child bearing potential - are you using a highly effective form of contraception, which means methods that are 99% effective?

Examples: oral pill, implant or injection, IUD/IUS, sterile partner, true abstinence, sterile or post-menopausal.

Yes - highly effective contraception

No - not highly effective contraception

N/A - not of child bearing potential

Not Eligible

Examples of highly effective contraception include: - Established use of oral, injected or implanted hormonal methods of contraception - Placement of IUD or IUS - Sterilised male partner (permanent) with post-vasectomy confirmation - True abstinence: when this is in line with your preferred usual lifestyle

Examples of NON-acceptable methods: - Condoms or double barrier - Periodic abstinence (calendar, ovulation, symptothermal, post ovulation) - Spermicide

What method of birth control?

Are you currently pregnant or lactating?

Yes

Not Eligible

Do you smoke, use nicotine use or abuse drugs? (prescription or illegal substances)

Yes

Not Eligible

Do you have any allergies to any drugs, supplements or foods?

Exclude allergies to dairy

Yes

Please detail any allergies - what to and what reaction:

Screening Outcome*

Passed Screening

Failed Screening

Need to check

Waitlisted

Waitlist notes/Reason for Screen Fail:

Have you informed the participant that we have other studies recruiting that they may be eligible for?

Yes

I am pleased to inform you that you are eligible to participate in the trial, I will now issue you with your participant ID. Please make a note of this as you will use this on your questionnaires and all your results will only be identifiable by this code.

Participant ID*

If person fails screening or is not interested, please just type xxxx. Do NOT put the actual participant ID in this field unless they have PASSED screening.

Are you happy to proceed with enrolment? I will start by asking a few baseline questions while we are on the phone.*

Yes

Participant Details

Are you currently working?*

Full Time

Part Time/Casual

Retired

Unemployed

Other

Do you have children living at home with you?*

Yes

Are you currently following any particular diet, such as vegetarian, keto etc. If yes, please provide details:

Are you diabetic?*

if YES please let the participant know that they will be excluded from the 6 hour urine test, and to ignore references to this in their upcoming emails.
if YES, Please make a note in AC not to send a urine kit to this participant

Yes

Are you allergic to lactulose or mannitol?*

Yes

Do you exercise regularly?*

Yes

Thanks for answering those questions. Next we will send out a consent form for you to complete, and once we get that back from you, we'll enrol you in our system, and give you a call to book you in for your initial appointment.

There's a 28 day pre-study period before your initial appointment, during which you'll need to complete questionnaires and diet recalls that we will email to you when due. You will also need to collect stool and urine samples just before your baseline appointment.
The urine sample will be taken over a period of 6 hours. You will collect all of your urine, then from this collection you'll prepare a smaller sample to bring with you to your appointment. As such we recommend taking your sample on a day where you will have access to a private bathroom.
We'll work out the timing of this with you once we schedule your initial appointment.

Thanks for answering those questions. Next we will send out a consent form for you to complete, and once we get that back from you, we'll get you set up you in our system, and give you a call to determine the best time for you to start your 28 day pre-study process.

During these 28 days you'll need to complete questionnaires and diet recalls that we will email to you when due. In the final 3 days (between day 25 and 28) you will need to collect stool and urine samples and attend ACL for your blood test and some basic measurements..
The urine sample will be taken over a period of 6 hours. You will collect all of your urine, then from this collection you'll prepare a smaller sample which you'll need to post to the lab in the pre-addressed envelope. We recommend taking your sample on a day where you will have access to a private bathroom.

Do you have any final questions?