All studies
Not yet recruitingOBSERVATIONAL

Association Between Composition of the Gut Microbiota and Nutritional Status in Digestive Oncology

This study explores the connection between the tiny living things (microbes) in our gut and mouth, and how well people with digestive cancer are nourished. Many cancer patients struggle with malnutrition, which can make treatments harder and lead to more health problems. We know that these microbes can affect appetite, how our body uses food, and how well we digest things. This research aims to understand these links better in patients starting chemotherapy for digestive cancer. By looking at stool and saliva samples, along with diet and health information, the study hopes to find new ways to improve nutritional care and support for cancer patients.

At a glance

Status
Not yet recruiting
Sponsor
Hospices Civils de Lyon
Enrolment target
150
Start
01 Dec 2025
Estimated completion
01 Dec 2027

What is this study about?

When someone is diagnosed with cancer, especially digestive cancers, staying well-nourished can be a big challenge. Many patients experience malnutrition, which means their body isn't getting enough important nutrients. This can make them feel weaker, lead to more side effects from treatments, and increase the risk of infections or needing to stay in hospital longer. Cancer treatments themselves can sometimes make this worse by causing side effects like a poor appetite or changes in taste.

Doctors and nurses already use different methods to help patients with nutrition, like advising on diet or providing special supplements. However, these methods don't work the same for everyone. Researchers are now looking at something called the 'microbiota' – that's the community of tiny living things, like bacteria, that live in our gut and mouth. These microbes play a surprisingly big role in our health, including how we digest food, our appetite, and how our body uses energy.

This study, called ONCONUTRIBIOTA, wants to see if changes in these microbes are connected to how well-nourished people with digestive cancer are while they undergo chemotherapy. By understanding this link, the researchers hope to find new ways to improve nutritional support for patients. This could lead to better treatments or ways to identify patients who might need extra help, ultimately making their cancer journey a bit easier.

Key takeaways

  • Exploring link between gut bugs and nutrition in digestive cancer patients.
  • Aims to improve nutritional support during chemotherapy.
  • Involves providing stool and saliva samples during routine visits.
  • No new medications; it's an observational study.
  • Participation helps future cancer patients by advancing knowledge.
  • You can withdraw from the study at any time without affecting your care.

Who may be eligible?

This study is looking for adults who have digestive cancer, such as certain types of pancreatic or bowel cancer. You would need to be starting chemotherapy for your cancer and be able to eat food normally by mouth. It’s important that you are generally feeling well enough to take part and can give stool and saliva samples.

There are certain reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you've recently taken antibiotics (unless it was for surgery protection). Also, if you have other serious medical conditions, certain types of brain tumours, or have had extensive surgery on your digestive system, you might not be eligible. If you're already in another medical study involving medication, or if you've had chemotherapy for a different cancer recently, you might also not be able to participate. The study will check these details carefully.

Ultimately, your doctor and the study team will help determine if this study is right for you, based on all your health information and if you are living in France and are part of the French health system.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you an adult aged 18 or over?
  2. Do you have pancreatic or bowel cancer and are starting chemotherapy?
  3. Are you able to eat food by mouth?
  4. Are you generally well enough to participate (Performance Status ≤2)?
  5. Have you not taken antibiotics in the last 3 weeks (unless for surgery)?
  6. Are you able to provide stool and saliva samples?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your involvement would be quite light and would fit into your regular hospital visits for chemotherapy. You would be seen twice: once on the day you start your first chemotherapy treatment, and again when you finish that first round of chemotherapy.

During these two visits, you would be asked to provide small samples of your stool (poo) and saliva (spit). You would also fill out some questionnaires about your general well-being and how your nutrition is affecting your quality of life. The team will also do some tests to check your sense of smell and taste, and measure various things that help them understand your nutritional status and overall health. There are no new medications involved, as this is an 'observational' study, meaning the researchers are just watching and learning, not giving you any new treatments. The total duration of your active participation will be while you complete your first cycle of chemotherapy, which typically lasts a few weeks.

Potential risks and benefits

Taking part in this study doesn't involve any new medical treatments or procedures beyond what you would normally have for your cancer care. This means there are no direct medical risks from participating, and the samples you provide (stool and saliva) are very straightforward. The main benefit for you is knowing you are contributing to important research that could help future cancer patients have better nutritional support. While you won’t personally receive new treatments from this study, the information gathered might lead to better understanding and care for others. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

  • Edouard Herriot Hospital - medical oncology department
    Verified postcode
    Lyon, France
  • Croix Rousse Hospital Hepatology and Gastroenterology Department
    Verified postcode
    Lyon, France
  • Lyon Sud Hospital - Hepatology and Gastroenterology Department
    Verified postcode
    Lyon, France

Common questions

What is the 'gut microbiota'?

It's the community of trillions of tiny living things, like bacteria, that live in your digestive system. They play a big role in your health.

Will I receive any new treatment in this study?

No, this is an observational study. You will continue to receive your standard chemotherapy treatment. The study mainly involves collecting samples and information.

How many times will I need to visit the hospital for the study?

You'll be part of the study during two of your routine chemotherapy visits: at the start of your first cycle and at the end of it.

Will taking part affect my regular cancer treatment?

No, your regular cancer treatment will not be affected. You will receive the same care whether you join the study or not.

What kind of samples will be collected?

You'll be asked to provide a stool (poo) sample and a saliva (spit) sample during your two study visits.

How to find out more

Nicolas Benech, Dr

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Association Between Composition of the Gut Microbiota and Nu…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.