Crohn´s disease

Crohn’s disease is a chronic inflammation of the intestines that periodically will present itself as abdominal pain, diarrhoea and weight loss; in-between periods of no or little symptoms.

Indications

Crohn’s disease is a chronic inflammation of the intestines that periodically will present itself as abdominal pain, diarrhoea and weight loss; in-between periods of no or little symptoms. The disease affects patients in their twenties and once the disease begins, it tends to be a chronic, recurrent condition with periods of remission and disease exacerbation. At times symptoms are scarce but at present there is no known cure for the disease. It primarily causes ulcerations in the small and large intestines, but can affect the digestive system anywhere between the mouth and the anus. The affected parts of the intestine are red and swollen and sores and bleeding ulcers can arise. When the inflammation heals scarred tissue may result in intestinal constrictions. 

The cause of Crohn’s disease is not known, although it does seem to run in the family. One theory is that the body's immune system reacts to a virus or bacteria by causing ongoing inflammation in the intestine mucous membrane and deep tears (fistulas) in the intestine wall. The disease is more common in smokers. 

Depending on how large part of the intestine is involved the symptoms will vary accordingly. Many patients will have felt weak symptoms for several years before a diagnosis. Symptoms vary from fever, persistent diarrhoea (loose, watery or frequent bowel movements), crampy abdominal pain (due to constrictions in the intestine), fatigue (since the body’s ability to absorb nutrients from food is reduced), loss of appetite with subsequent weight loss and a sense of sickness. Some patients may develop tears (fissures), which may cause pain and bleeding, especially during bowel movements. Inflammation may also cause a fistula to develop. A fistula is a tunnel that leads from one loop of intestine to another. 

However, the disease is not always limited to the GI tract; it can also affect the joints, eyes, and skin. In certain cases it can also affect the liver and kidneys and there is an increased risk for blood clots and intestinal cancer. In general, though, people with Crohn's disease lead full or almost full, active, and productive lives. Several studies show that the life expectancy is not reduced. 

In Sweden 500 patients a year are diagnosed with Crohn’s disease and it is believed that the prevalence is 30 000 people. It is slightly more common in women than in men.


Clinical studies

AF treatment in ulcerative colitis

A randomised double-blind study was performed to see if AF inducing cereals could promote endogenous AF production in patients with ulcerative colitis and Crohn's disease, and to determine if an elevated AF level was correlated to clinical improvement of intestinal function.

The experimental group consisted of 26 patients given AF inducing cereals as muesli, bread and/or pasta in addition to their regular diet during 30 days. A control group of 24 received a similar diet without the AF inducing properties. Patients were asked to keep a diary over bowel symptoms, and plasma levels of AF and rectal biopsies were evaluated before and after treatment.

Results showed that the patients receiving active treatment significantly improved intestinal function correlating to increased plasma AF levels (p<0,001). Elevated AF levels were sustained one month after treatment. No effect was seen in the placebo group (fig. 1). A significant accumulation of AF in intestinal epithelial cells of the active treatment group was seen with colonic biopsies.

Subjective ratings of clinical symptoms according to VAS were significantly improved (p<0,05) in the group receiving active treatment (mean +34,6%) compared with placebo (mean 15,4%) (fig. 2).

Figur1. Patients treated with specially processed cereals (SPC) has significantly higher AF-levels in plasma compared to placebo. SPC-treated patients also got a significant better intestinal function.

Figure 2. AF-treated patients showed a significant improvement in subjective symptons as compared to the placebo group.

Due to the findings of this study the surgeons have begun AF-treatment of more patients undergoing GI-surgery in which through experience the outcome is known to lead to reduced intestinal function.

The treatment is initiated by already on the first day administer Salovum® dissolved in ordinary juice. This will quickly lead to high AF levels in the intestine without first letting the body produce it by its own. Most often the patients initially treated with Salovum® for 5-10 days can then be transferred to the AF inducing SPC-Flakes® in order to stimulate the endogenous AF production.

Björck, Bosaeus, Ek, Jennische, Lönnroth, Johansson and Lange, Food induced stimulation of the antisecretory factor can improve symptoms in human inflammatory bowel disease: A study of a concept, Gut, 2000; 46:824-829, view link

SPC-Flakes® in the treatment of severe Crohn's disease

Prior positive results from AF-treatment on Crohn's patients encouraged an open study on a group of six patients with severe, prolonged treatment resistant Crohn's disease. Patients were treated with AF inducing cereals during three months. Clinical symptoms, blood samples, endoscopic and histological examination, CDAI (Crohn's Disease Activity Index) and quality of life (SF-36) were evaluated.

A continuous and significant improvement of clinical symptoms and quality of life measurements was seen as well as histological improvement. Findings from this and earlier studies show the anti-inflammatory activity of the specially processed AF inducing cereals. It is most likely that it is the anti-inflammatory activity that is of greatest importance in the treatment of Crohn's patients.

Shafazand, Eriksson, Jennische och Lange, Födoinducerad ökning av antisekretorisk faktor förbättrade det kliniska tillståndet hos sex patienter med svår Crohns sjukdom, Posterpresentation vid Riksstämman, 2003

SPC-Flakes® in IBD in children

The first pilot study in children with ulcerative colitis and Crohn's disease revealed that the clinical symptoms improved and that treatment with SPC-Flakes is a safe and well tolerated treatment. The positive study results will be followed up with a randomised double-blind study.

Finkel, Bjarnason, Lindblad and Lange, Specially Processed Cereals: A clinical innovation for children suffering from inflammatory bowel disease?, Scand J of Gastroenterol, 2004; 39:87-88, view link  


Expected treatment outcome

SPC-Flakes® is a maintenance treatment and the purpose is to stimulate the body’s own production of the AF protein. A positive therapeutic response can normally be seen after 10-15 days. The treatment should last at least one month to determine the effect of the treatment. After termination of the treatment AF levels will decline again after a few weeks. If treatment is resumed, AF levels will rise within a matter of days, indicating a biological memory for AF production. 

In the absence of a treatment effect with SPC-Flakes® this may be due to the dose being too low or that some patients’ bodies are unable to produce AF. Clinical studies demonstrate that these patients might be helped with Salovum® which is a way of supplying high doses of the AF protein without having the body produce it on its own.


Dosage

Normal dosage of AF-inducing cereals, SPC-Flakes®, is 1 g/kg bodyweight daily, divided into 2-3 occasions. When treating children the dose may need to be increased and when treating elderly it may need to be reduced. The dosage should be introduced step by step and reach full dosage after 4-6 days. The cereals can be eaten with yoghurt or boiled to a porridge without loosing the effect. 1 dl of SPC-Flakes® equals approximately 50 g.

 


Side effects, interactions and precautions

AF products have been eaten by tens of thousands of individuals and no side effects of medical nature have been reported. A few patients have experienced occasional constipation, but this discomfort can be reduced by a step-by-step introduction of the treatment. 

There are no reported interactions with concomitant medications. This is of importance as the patients should continue with their regular medical treatment. SPC-Flakes® should not replace or change the patients’ current medication. Persons with coeliac disease or gluten intolerance should not be treated with SPC-Flakes®.


Where to buy, Prescriptions

SPC-Flakes® can be bought prescription free in pharmacies or in health food shops. As of December 31, 2010, Läkemedelsverket (The Medical Products Agency) has decided to include SPC-Flakes® and Salovum® in the new revised list for food for particular nutritional use for children under 16 years of age (“Särnär”, LVFS 2010:27 ) and the cost will thus be included within the national benefit scheme for prescription drugs.
For patients 16 years of age or older, dieticians and most doctors can prescribe SPC-Flakes® as “sär-när”, foods for particular nutritional uses certified by the National Food Administration (Livsmedelsverket). The cost of the products varies between the different counties (landsting).