Advice Pool - Health and Fitness

Managing stress in your life is a great way to help get your negative emotions under control, but unfortunately, stress is only one of many IBS causes. In fact, research that has been conducted over

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

the past few years has found that IBS may also be related to Small Intestinal Bacterial Overgrowth (SIBO).

What is SIBO? It is an overgrowth of bacteria that naturally occurs in the small intestin

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

e. The small intestine contains a small amount of bacteria that is essential to the proper functioning of the gastrointestinal tract. However, when too much bacteria exists, problems such as fat ma

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

labsorption occur. In addition, it also stops carbohydrates from being absorbed, leaving them to rot in the intestines causing a number of unpleasant and often foul-smelling symptoms including bloat

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ing, pain, gas, mucus in stools and diarrhea.

Bacterial overgrowth can lead to nutrient deficiencies, food allergies and digestive enzymes that barely function. It is a common condition that usuall

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

y goes undetected for years, even when symptoms are present. Why? Most people who have chronic digestive problems and have bloating, gas, diarrhea and constipation are typically diagnosed with irri

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

table bowel syndrome. Doctors rarely consider bacterial overgrowth in the small intestine as the problem.

What causes bacterial overgrowth? There are many different factors that can lead to SIBO.

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

Some of the following conditions that could cause an overgrowth of bacteria in the small intestine include:

•Reduction of motility in the small intestine – condition caused by too much dietary suga

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

r and chronic stress. This condition can also occur from diabetes, scleroderma and hypothyroidism.

•Structural abnormalities within the small intestine – abnormalities may be caused by small intest

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

inal diverticula, gastric bypass surgery, and intestinal obstruction. etc.

•Hypochlorhydria – As people age, they produce less stomach acid. Stomach acid helps to eliminate bacteria in the small in

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

testine. Thus, if there is a decline, the acid won’t be able to eliminate enough of the bacteria.

•Other causes – stress, prolonged use of steroids, antibiotics, antacids, birth control pills and o

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ther medications, immune deficiency, pancreatic enzyme deficiency and a diet insufficient in fiber.

Are IBS and SIBO related?

One study that was conducted by researches at the Cedars-Sinai Medical

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

Centre in California involved 202 participants with IBS. Each participant was tested for bacterial overgrowth with a lactulose breath hydrogen test. A person with bacterial overgrowth produces high

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

levels of methane or hydrogen gas. The lactulose hydrogen test analyses the gas in breath, and is the best test for diagnosing SIBO.

At the end of the study it was found that of the 202 participan

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ts, 157 tested positive for SIBO. When the 157 people that were diagnosed with SIBO were treated for the condition, and the extra bacteria within their intestine were eliminated, 48% of them had an

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

improvement in their IBS symptoms.

Although it has been found that bacterial overgrowth and IBS can co-exist, researchers are still determining whether or not IBS symptoms are caused by SIBO. Some

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

theories suggest that the high levels of methane or hydrogen gas that are caused by the overgrowth of bacteria produce IBS symptoms. However, the theories are yet to be proved.

How do you treat S

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

IBO?

Excess bacteria are eliminated through the use of antibiotics. Unfortunately, although antibiotics can control bacteria overgrowth it isn’t a cure. Like IBS, SIBO symptoms often return when m

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

edication is ceased. Thus, antibiotic treatment is often a continuous process.

If you think you may have SIBO, talk to your doctor about taking a lactulose hydrogen test. If you find that SIBO is

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

related to your IBS causes, or even if it’s not, it is a good idea to look into other alternative and complimentary forms of therapy to treat your symptoms such as acupuncture aside from medications.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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